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8 jobs found in madison, new jersey

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    • somerville, new jersey
    • contract
    • $38 - $43.64 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!   location: Somerville, New Jersey job type: Contract salary: $38.00 - 43.64 per hour work hours: 9 to 5 education: Masters   responsibilities: - Design and conduct innovative polymer /PAG synthesis and characterization of new materials - Develop new platforms and optimize formulations to improve the performance of targeted products - Communicate and present the research test results with the team and department manager in weekly meetings and monthly reports with scientific logic and conclusion. - Proactively seek and provide ideas to address technical issues. As assigned by manager, participate in customer meetings and prepare update files for customers.   qualifications: - MS plus 1-2 yrs exp or PhD degree in organic, polymer chemistry or related materials science fields, working experience in polymer synthesis and characterization, photochemistry, or semiconductor related applications desired. - Good understanding of IC packaging technology and principles of photoresist application/ theory, as well as resist related chemistry. - Operating FAB and photoresist processing and testing equipment's, such as lithographic exposure tools, coating & development tracks etc. - Experience in dealing with chemical vendors and IC customers is a plus.   skills: Chemistry Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!   location: Somerville, New Jersey job type: Contract salary: $38.00 - 43.64 per hour work hours: 9 to 5 education: Masters   responsibilities: - Design and conduct innovative polymer /PAG synthesis and characterization of new materials - Develop new platforms and optimize formulations to improve the performance of targeted products - Communicate and present the research test results with the team and department manager in weekly meetings and monthly reports with scientific logic and conclusion. - Proactively seek and provide ideas to address technical issues. As assigned by manager, participate in customer meetings and prepare update files for customers.   qualifications: - MS plus 1-2 yrs exp or PhD degree in organic, polymer chemistry or related materials science fields, working experience in polymer synthesis and characterization, photochemistry, or semiconductor related applications desired. - Good understanding of IC packaging technology and principles of photoresist application/ theory, as well as resist related chemistry. - Operating FAB and photoresist processing and testing equipment's, such as lithographic exposure tools, coating & development tracks etc. - Experience in dealing with chemical vendors and IC customers is a plus.   skills: Chemistry Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • totowa, new jersey
    • permanent
    • $46,000 - $49,000 per year
    Pharmacy Technician Location | Totowa, NJ Department | Network Operations, Pharmacy Reports To | Pharmacist-in-Charge Overview The Pharmacy Technician will perform laboratory and pharmacy related duties under the direct supervision of an authorized Nuclear Pharmacist. This job involves working in a clean room as well as occupational exposure to radiation. salary: $46,000 - $49,000 per yearshift: Firstwork hours: 10 AM - 6 PMeducation: High` SchoolResponsibilities Perform the duties associated with compounding, dispensing, and distribution of FDG and NaF, including data entry with Pinestar for end-of-day reports and daily dose management reports. Ensure compliance with USP <797>, <823>, proposed <825> regulations, or other state pharmacy requirements as applicable, at the site level; maintain personal license in good standing through applicable state laws. Complete cGMP documents as required within Quality Management System. Ensure aseptic operations follow internal procedures (gowning, cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulations. Maintain a clean and safe working environment. Perform radiation safety duties according to Corporate Radiation Compliance Program and site licensing requirements. Provide quality customer service associated with radiopharmaceuticals to physicians, healthcare workers, customers, etc.  Take orders from customers as applicable by state regulations SkillsPharmaceuticalCertificationLicensureSterile CompoundingAseptic OperationsMicrosoft OfficeQualificationsYears of experience: 2 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    Pharmacy Technician Location | Totowa, NJ Department | Network Operations, Pharmacy Reports To | Pharmacist-in-Charge Overview The Pharmacy Technician will perform laboratory and pharmacy related duties under the direct supervision of an authorized Nuclear Pharmacist. This job involves working in a clean room as well as occupational exposure to radiation. salary: $46,000 - $49,000 per yearshift: Firstwork hours: 10 AM - 6 PMeducation: High` SchoolResponsibilities Perform the duties associated with compounding, dispensing, and distribution of FDG and NaF, including data entry with Pinestar for end-of-day reports and daily dose management reports. Ensure compliance with USP <797>, <823>, proposed <825> regulations, or other state pharmacy requirements as applicable, at the site level; maintain personal license in good standing through applicable state laws. Complete cGMP documents as required within Quality Management System. Ensure aseptic operations follow internal procedures (gowning, cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulations. Maintain a clean and safe working environment. Perform radiation safety duties according to Corporate Radiation Compliance Program and site licensing requirements. Provide quality customer service associated with radiopharmaceuticals to physicians, healthcare workers, customers, etc.  Take orders from customers as applicable by state regulations SkillsPharmaceuticalCertificationLicensureSterile CompoundingAseptic OperationsMicrosoft OfficeQualificationsYears of experience: 2 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • whippany, new jersey (remote)
    • contract
    • $42.85 - $50.41 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!   location: Whippany, New Jersey job type: Contract salary: $42.85 - 50.41 per hour work hours: 8 to 4 education: Bachelors   responsibilities: This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation. DEPARTMENT/TEAM DESCRIPTION Operational Excellence and Project Management in Global Medical Affairs (GMA), Oncology SBU is a global function which partners and collaborates with the MA Teams and Key Stakeholders (internal and external) to assist in achieving short and long term strategic goals while adhering to "LIFE" values (leadership, integrity, flexibility, efficiency). POSITION SUMMARY The Senior Contract Operations Excellence & PM Manager position is accountable for compliant and high quality management of GMA company-sponsored studies (both non and interventional), Investigator Initiated Research (IIR) and Investigator-Sponsored Collaborative Studies (ISCS) data acquisition projects, and Expanded Access Programs (EAPs) POSITION DUTIES & RESPONSIBILITIES Lead all aspects of clinical studies from planning to execution. Assigned studies include interventional, non-interventional and data acquisitions within Global Medical Affairs Oncology SBUOverall accountable for study management of assigned studies, serve as primary contact for CRO. Lead and manage multi-disciplinary cross functional team in all aspects of studies activities including but not limited to site start up, CRO/vendor selection and management, study-specific timelines and study executionCoordinate for fair market value assessment of study budgets; initiate and manage contracting process. Liaise with appropriate internal protocol review committees to ensure timely review, response and finalization of the protocol and protocol amendmentIIR and/or ISCS data acquisition projects. Responsibilities include chair conference calls, coordinate between team and IIR-sponsors on activities such as data review, query resolution and independent review of imaging scans, when applicable. Develop and manage overall project timelinesSupport GMA Medical Leads on overall delivery of the data generated from Oncology Non-Interventional Studies (NIS). Responsibilities include, but not limited to, monitor country/site selection and activation process, contribute in CRF design and review, study budget management, support Medical Leads on clinical data consistency review to ensure that data issues raised during medical and DM data review are adequately queried and resolvedManage study drug forecasting. Liaise with Clinical Supplies Management to ensure drug supply planning, labeling and distribution are executed timely and within applicable country and regional guidelinesAssist and/or lead in executing Expanded Access Programs within Oncology MA. Responsibilities include collaborate with country affiliates and Medical Experts as appropriate to ensure timely alignment and execution of country specific processes including permit license application, commercial product transition plan, and Real World Data (RWD) data generation when applicable  qualifications: SKILLS Extensive (7+ years) study management experience involving Phases 2 & 3 studies from planning through regulatory submission; regulatory submission experience a plusUnderstanding of the connection between protocol endpoints, study design, CRF design and data collection; clinical science backyard a plusAt least 5 years Oncology experience (can be outside of industry)Strong written, organizational, and computer (e.g. Excel, power point) skillsExcellent interpersonal and communication skills as candidate will interact with cross functional team members as well as liaise with external academic networks and cooperative groups from all over the global Preferences: Medical Affairs experience preferred REQUIREMENTS/PREFERENCES Education Requirement(s): Bachelor's degree required; life science preferredMasters in Science or Business Administration - preferred  skills: MS-EXCEL, Study Planning Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!   location: Whippany, New Jersey job type: Contract salary: $42.85 - 50.41 per hour work hours: 8 to 4 education: Bachelors   responsibilities: This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation. DEPARTMENT/TEAM DESCRIPTION Operational Excellence and Project Management in Global Medical Affairs (GMA), Oncology SBU is a global function which partners and collaborates with the MA Teams and Key Stakeholders (internal and external) to assist in achieving short and long term strategic goals while adhering to "LIFE" values (leadership, integrity, flexibility, efficiency). POSITION SUMMARY The Senior Contract Operations Excellence & PM Manager position is accountable for compliant and high quality management of GMA company-sponsored studies (both non and interventional), Investigator Initiated Research (IIR) and Investigator-Sponsored Collaborative Studies (ISCS) data acquisition projects, and Expanded Access Programs (EAPs) POSITION DUTIES & RESPONSIBILITIES Lead all aspects of clinical studies from planning to execution. Assigned studies include interventional, non-interventional and data acquisitions within Global Medical Affairs Oncology SBUOverall accountable for study management of assigned studies, serve as primary contact for CRO. Lead and manage multi-disciplinary cross functional team in all aspects of studies activities including but not limited to site start up, CRO/vendor selection and management, study-specific timelines and study executionCoordinate for fair market value assessment of study budgets; initiate and manage contracting process. Liaise with appropriate internal protocol review committees to ensure timely review, response and finalization of the protocol and protocol amendmentIIR and/or ISCS data acquisition projects. Responsibilities include chair conference calls, coordinate between team and IIR-sponsors on activities such as data review, query resolution and independent review of imaging scans, when applicable. Develop and manage overall project timelinesSupport GMA Medical Leads on overall delivery of the data generated from Oncology Non-Interventional Studies (NIS). Responsibilities include, but not limited to, monitor country/site selection and activation process, contribute in CRF design and review, study budget management, support Medical Leads on clinical data consistency review to ensure that data issues raised during medical and DM data review are adequately queried and resolvedManage study drug forecasting. Liaise with Clinical Supplies Management to ensure drug supply planning, labeling and distribution are executed timely and within applicable country and regional guidelinesAssist and/or lead in executing Expanded Access Programs within Oncology MA. Responsibilities include collaborate with country affiliates and Medical Experts as appropriate to ensure timely alignment and execution of country specific processes including permit license application, commercial product transition plan, and Real World Data (RWD) data generation when applicable  qualifications: SKILLS Extensive (7+ years) study management experience involving Phases 2 & 3 studies from planning through regulatory submission; regulatory submission experience a plusUnderstanding of the connection between protocol endpoints, study design, CRF design and data collection; clinical science backyard a plusAt least 5 years Oncology experience (can be outside of industry)Strong written, organizational, and computer (e.g. Excel, power point) skillsExcellent interpersonal and communication skills as candidate will interact with cross functional team members as well as liaise with external academic networks and cooperative groups from all over the global Preferences: Medical Affairs experience preferred REQUIREMENTS/PREFERENCES Education Requirement(s): Bachelor's degree required; life science preferredMasters in Science or Business Administration - preferred  skills: MS-EXCEL, Study Planning Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • ridgefield, new jersey
    • temp to perm
    • $22 - $23 per hour
    job summary: Compounding Associate - 4 OPENINGS Ridgefield, NJ 2 nd shift - 3:30pm - Midnight (M-F) Train on 1 st shift for 4 weeks. 7am - 3:30pm (M-F)   location: Ridgefield, New Jersey job type: Temporary salary: $22 - 23 per hour work hours: 3 to 11 education: High School   responsibilities: Compounding Associate will be responsible of the following: Verify all chemicals being added Closely follow compounding instructions Identify each chemical pre-weighed with information tag / initial Document all required information on batch card, verify and initial Follow all SOPs and WIs Keep compounding area clean and organized Follow all safety rules. Follow all GMP and company policies/procedures. Work on special projects as required   qualifications: Requirements High School Diploma or GED 2-5 years relevant blending or compounding experience, cosmetic or personal care setting preferred. Ability to read, understand, document and maintain records as required. Ability to handle multiple priorities in a fast-paced environment. Familiar with inventory control using RF scanning. Ability to lift up to 55 lbs. frequently   skills: GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: Compounding Associate - 4 OPENINGS Ridgefield, NJ 2 nd shift - 3:30pm - Midnight (M-F) Train on 1 st shift for 4 weeks. 7am - 3:30pm (M-F)   location: Ridgefield, New Jersey job type: Temporary salary: $22 - 23 per hour work hours: 3 to 11 education: High School   responsibilities: Compounding Associate will be responsible of the following: Verify all chemicals being added Closely follow compounding instructions Identify each chemical pre-weighed with information tag / initial Document all required information on batch card, verify and initial Follow all SOPs and WIs Keep compounding area clean and organized Follow all safety rules. Follow all GMP and company policies/procedures. Work on special projects as required   qualifications: Requirements High School Diploma or GED 2-5 years relevant blending or compounding experience, cosmetic or personal care setting preferred. Ability to read, understand, document and maintain records as required. Ability to handle multiple priorities in a fast-paced environment. Familiar with inventory control using RF scanning. Ability to lift up to 55 lbs. frequently   skills: GMP (Good Manufacturing Practice) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • ridgefield, new jersey
    • contract
    • $22 - $27.82 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Ridgefield, New Jersey job type: Contract salary: $22.00 - 27.82 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Responsible for designing, developing, and updating required technical documentation.Responsible for technical writing/editing for all types of documentation produced within a modern software development environment.Utilize knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.Document programming standards and procedures.Track and review change control documentation.Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements.Must be able to work quickly with a high degree of accuracy.Must possess sound interpersonal and information gathering skills, be able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others.Review current documents- incorporate comments from Manager.Navigate through company pasteur EDoc (Documentum) system utilizing current templates.Notify manager of workflow status and issues.Incorporate comments from team members and provide status to manager on review and approval workflow.Follow up with team members on comments  qualifications: Technical writing abilities and good time management.Strong root cause analysis skills with experience regarding quality standards.Be able to establish working relationships with other support and production areas in order to gather all the necessary information required.Must be proficient in EDoc with a working knowledge of templates, workflows and approval process.Proficient in MS Word, Excel, Powerpoint and Outlook. Interact well with a diverse group of individuals.Self-motivated and willing to be proactive in resolving issues.Excellent Verbal and written communication skills.Ability to work in a team environment.Education: University graduate preferred. Secondary Education diploma a requirementYears of Experience: 3 - 6 Years  skills: SOP, MS-WORD, MS-EXCEL, MS-Powerpoint Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Ridgefield, New Jersey job type: Contract salary: $22.00 - 27.82 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Responsible for designing, developing, and updating required technical documentation.Responsible for technical writing/editing for all types of documentation produced within a modern software development environment.Utilize knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.Document programming standards and procedures.Track and review change control documentation.Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements.Must be able to work quickly with a high degree of accuracy.Must possess sound interpersonal and information gathering skills, be able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others.Review current documents- incorporate comments from Manager.Navigate through company pasteur EDoc (Documentum) system utilizing current templates.Notify manager of workflow status and issues.Incorporate comments from team members and provide status to manager on review and approval workflow.Follow up with team members on comments  qualifications: Technical writing abilities and good time management.Strong root cause analysis skills with experience regarding quality standards.Be able to establish working relationships with other support and production areas in order to gather all the necessary information required.Must be proficient in EDoc with a working knowledge of templates, workflows and approval process.Proficient in MS Word, Excel, Powerpoint and Outlook. Interact well with a diverse group of individuals.Self-motivated and willing to be proactive in resolving issues.Excellent Verbal and written communication skills.Ability to work in a team environment.Education: University graduate preferred. Secondary Education diploma a requirementYears of Experience: 3 - 6 Years  skills: SOP, MS-WORD, MS-EXCEL, MS-Powerpoint Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • somerset, new jersey
    • permanent
    • $110,000 - $130,000 per year
    Company overview: well - established & rapidly growing Radiopharmacy that specializes in molecular diagnostics & therapeutics & has locations across the United States!  Position overview: the Nuclear Pharmacist will compound and dispense radiopharmaceuticals. This job involves working in a clean room as well as occupational exposure to radiation. While reporting into Network Operations, the Nuclear Pharmacist role is instrumental to the Quality Assurance Program and will work closely with the QA division at the site-level. salary: $110,000 - $130,000 per yearshift: Firstwork hours: 8 AM - 5 PMeducation: BachelorResponsibilities Perform duties associated with compounding, dispensing, and distribution of radiopharmaceuticals, including data entry with Pinestar for end-of-day reports and daily dose management reports Perform the duties associated with synthesis, quality control, and quality assurance of FDG and NaF, including reagent preparation Ensure compliance with USP <797>, <823>, proposed <825> regulations, or other state pharmacy requirements as applicable, at the site level; maintain personal license in good standing through applicable state laws Ensure compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Parts 211 and 212 requirements, by adhering to the quality management system and maintain a state of cGMP control at the site Ensure aseptic operations follow internal procedures (gowning, cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulations Ensure compliance with radiation and laboratory safety SkillsB.S. Pharmaceutical SciencePharm.DQualificationsYears of experience: 2 yearsExperience level: Entry LevelRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    Company overview: well - established & rapidly growing Radiopharmacy that specializes in molecular diagnostics & therapeutics & has locations across the United States!  Position overview: the Nuclear Pharmacist will compound and dispense radiopharmaceuticals. This job involves working in a clean room as well as occupational exposure to radiation. While reporting into Network Operations, the Nuclear Pharmacist role is instrumental to the Quality Assurance Program and will work closely with the QA division at the site-level. salary: $110,000 - $130,000 per yearshift: Firstwork hours: 8 AM - 5 PMeducation: BachelorResponsibilities Perform duties associated with compounding, dispensing, and distribution of radiopharmaceuticals, including data entry with Pinestar for end-of-day reports and daily dose management reports Perform the duties associated with synthesis, quality control, and quality assurance of FDG and NaF, including reagent preparation Ensure compliance with USP <797>, <823>, proposed <825> regulations, or other state pharmacy requirements as applicable, at the site level; maintain personal license in good standing through applicable state laws Ensure compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Parts 211 and 212 requirements, by adhering to the quality management system and maintain a state of cGMP control at the site Ensure aseptic operations follow internal procedures (gowning, cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulations Ensure compliance with radiation and laboratory safety SkillsB.S. Pharmaceutical SciencePharm.DQualificationsYears of experience: 2 yearsExperience level: Entry LevelRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • parsippany, new jersey
    • contract
    • $40 - $42.19 per hour
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With therapeutic areas that include Oncology, Vaccines, and Rare Diseases, our partner aims to make treatments streamlined, easily accessible, and globally produced. If you share their goal of approaching healthcare in a novel way, look no further - apply for your dream job now! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Parsippany, New Jersey job type: Contract salary: $40.00 - 42.19 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Ensure SLS quality systems are maintained consistent with cGMPs, company policies, site procedures and regulatory guidance. The quality systems to be maintained include, but not limited to, laboratory investigations, instrument/facility qualifications, analytical method validation and transfers, deviation management, notification to management, corrective and preventive actions (CAPAs), site quality review team (SQRT) and change management.Ensure testing/administration is conducted in a manner consistent with cGMPs, company policies, site procedures and regulatory guidance. Position Responsibilities:Review/approve various types of laboratory documentation ensuring that strong scientific justification, adequate impact assessments and appropriate definition of root cause and corrective actions are identified. These documents would include (but not limited to) stability study change control, equipment change control, corrective and preventive actions, quality notification reports, testing notes, instrument/facility qualifications, analytical method validation and transfers and laboratory investigation reports.Ensure site quality systems are consistent with cGMPs, company policies, site procedures and regulatory guidance.Able to interpret quality requirements, both internal and external, and apply them to real life situations in the pharmaceutical industry.Experience with the principles and application of quality risk management.Work together with the SLS management to assure that objectives and metrics are met.Contribute to quality assurance management team initiatives and objectives.Create, track and approve corrective/preventive action items to help ensure they are completed within the agreed timeframes.Ensure testing/administration are conducted in a manner consistent with cGMPs, company policies, site procedures and regulatory guidance.  qualifications: Bachelor's degree or higher in Chemistry/Biology or related discipline.Experience: 2-5 Years of related analytical chemistry/microbiology experience with a Bachelor's degree or 2-5 years working in a Quality Assurance position in the pharmaceutical industry. This experience should include authoring/approving analytical investigations and deviations.Experience with electronic laboratory support systems (gQTS, gLIMS, PDOCS) preferred.Experience with Human Performance and Risk Management principles is highly desirable.QC/QA experience in a drug product or API manufacturing environment is desirable.Excellent written and oral communication skills with the ability to summarize complex situations in an easily understandable narrative.Must be comfortable interacting with all levels of management in the organization  skills: CAPA, Biology, Chemistry Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With therapeutic areas that include Oncology, Vaccines, and Rare Diseases, our partner aims to make treatments streamlined, easily accessible, and globally produced. If you share their goal of approaching healthcare in a novel way, look no further - apply for your dream job now! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.   location: Parsippany, New Jersey job type: Contract salary: $40.00 - 42.19 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Ensure SLS quality systems are maintained consistent with cGMPs, company policies, site procedures and regulatory guidance. The quality systems to be maintained include, but not limited to, laboratory investigations, instrument/facility qualifications, analytical method validation and transfers, deviation management, notification to management, corrective and preventive actions (CAPAs), site quality review team (SQRT) and change management.Ensure testing/administration is conducted in a manner consistent with cGMPs, company policies, site procedures and regulatory guidance. Position Responsibilities:Review/approve various types of laboratory documentation ensuring that strong scientific justification, adequate impact assessments and appropriate definition of root cause and corrective actions are identified. These documents would include (but not limited to) stability study change control, equipment change control, corrective and preventive actions, quality notification reports, testing notes, instrument/facility qualifications, analytical method validation and transfers and laboratory investigation reports.Ensure site quality systems are consistent with cGMPs, company policies, site procedures and regulatory guidance.Able to interpret quality requirements, both internal and external, and apply them to real life situations in the pharmaceutical industry.Experience with the principles and application of quality risk management.Work together with the SLS management to assure that objectives and metrics are met.Contribute to quality assurance management team initiatives and objectives.Create, track and approve corrective/preventive action items to help ensure they are completed within the agreed timeframes.Ensure testing/administration are conducted in a manner consistent with cGMPs, company policies, site procedures and regulatory guidance.  qualifications: Bachelor's degree or higher in Chemistry/Biology or related discipline.Experience: 2-5 Years of related analytical chemistry/microbiology experience with a Bachelor's degree or 2-5 years working in a Quality Assurance position in the pharmaceutical industry. This experience should include authoring/approving analytical investigations and deviations.Experience with electronic laboratory support systems (gQTS, gLIMS, PDOCS) preferred.Experience with Human Performance and Risk Management principles is highly desirable.QC/QA experience in a drug product or API manufacturing environment is desirable.Excellent written and oral communication skills with the ability to summarize complex situations in an easily understandable narrative.Must be comfortable interacting with all levels of management in the organization  skills: CAPA, Biology, Chemistry Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    • south plainfield, new jersey (remote)
    • contract
    • $75 - $85 per hour
    job summary: The Contractor, Pharmacovigilance Operations contributes to oversight of the collection, processing, assessment, monitoring and follow-up of Adverse Event (AE) and Serious Adverse Event (SAE) reports from clinical trials and post-marketing sources. This is in compliance with Good Clinical Practice (GCP), and applicable global regulations and guidance documents. The incumbent monitors that AEs and SAEs are processed with a high degree of detail and accuracy and are reported in a timely manner. He/She is also responsible for monitoring that the Safety Database configuration meets applicable regulations, is kept current with products and studies, and that the vendor provides accurate outputs from the safety database in a timely manner. The incumbent works cross-functionally with internal departments and external resources on ICSR and safety database related matters.   location: South Plainfield, New Jersey job type: Contract salary: $75 - 85 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Participates in, and contributes to, the implementation and maintenance of a robust safety reporting system compliant with current applicable global regulations. This includes closely monitoring the PV vendor and the case workflow.Performs prospective and retrospective QC of cases to ensure ICSR quality and monitors that all cases move through the workflow steps to ensure compliance with regulatory timeframes. Supports and participates in training of the PV vendor on new products, protocols, and requirements.Reviews and contributes to any PV vendor documentation. This includes but may not be limited to Client Specific Guides and Safety Management Plans.Monitors configuration changes of the safety database by the vendor ensuring they are timely and meet PTC and regulatory requirements.Assists in case migrations with the vendor into the safety database monitoring quality, timeliness and complete documentation audit trail.Participates in business continuity arrangements. Assists with the authoring and implementation of PV Operations processes.Collaborates with medical monitor(s), PV leads and Regulatory Affairs to monitor the processing, submission and tracking of expedited safety reports to appropriate domestic and international regulatory authorities.Supports maintenance and archival of manual and electronic drug safety files pertaining to ICSR management.Reviews the quality of outputs from the safety database (or provide if needed) for signal meetings, safety summaries for Investigator Brochures (IBs), Developmental / Periodic Safety Update Reports (D/ PSURs) and Annual Reports.Performs other tasks and assignments as needed and specified by management.   qualifications: BSN/RN, Bachelor's degree in Biological Sciences, Pharmacy or PharmD degree or equivalent and a minimum of 5 years of progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, including experience within pharmacovigilance operations.Demonstrated expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.Extensive, hands-on working knowledge of MedDRA terminology and the processing of AEs/SAEs in the pharmaceutical industry.Extensive experience of QC and workflow monitoring to ensure quality and timeliness of case processing.Demonstrated ability to identify opportunities to improve the PV reporting process(es).Ability to influence without direct authority.Proficiency with Microsoft Office.Excellent verbal and written communication and skills.Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. Preferred: Understanding of safety database administration, configuration, data entry and extraction, specifically with Argus.Expertise in the use of Electronic Document Management System (eDMS) software.Expertise in MedDRA and WHODD with relevance to coding suspect drug and concomitant medications.  skills: Argus, SAE (Serious Adverse Event), AD (Adverse Events), ICSR (Individual Case Study Report), MedDRA Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: The Contractor, Pharmacovigilance Operations contributes to oversight of the collection, processing, assessment, monitoring and follow-up of Adverse Event (AE) and Serious Adverse Event (SAE) reports from clinical trials and post-marketing sources. This is in compliance with Good Clinical Practice (GCP), and applicable global regulations and guidance documents. The incumbent monitors that AEs and SAEs are processed with a high degree of detail and accuracy and are reported in a timely manner. He/She is also responsible for monitoring that the Safety Database configuration meets applicable regulations, is kept current with products and studies, and that the vendor provides accurate outputs from the safety database in a timely manner. The incumbent works cross-functionally with internal departments and external resources on ICSR and safety database related matters.   location: South Plainfield, New Jersey job type: Contract salary: $75 - 85 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Participates in, and contributes to, the implementation and maintenance of a robust safety reporting system compliant with current applicable global regulations. This includes closely monitoring the PV vendor and the case workflow.Performs prospective and retrospective QC of cases to ensure ICSR quality and monitors that all cases move through the workflow steps to ensure compliance with regulatory timeframes. Supports and participates in training of the PV vendor on new products, protocols, and requirements.Reviews and contributes to any PV vendor documentation. This includes but may not be limited to Client Specific Guides and Safety Management Plans.Monitors configuration changes of the safety database by the vendor ensuring they are timely and meet PTC and regulatory requirements.Assists in case migrations with the vendor into the safety database monitoring quality, timeliness and complete documentation audit trail.Participates in business continuity arrangements. Assists with the authoring and implementation of PV Operations processes.Collaborates with medical monitor(s), PV leads and Regulatory Affairs to monitor the processing, submission and tracking of expedited safety reports to appropriate domestic and international regulatory authorities.Supports maintenance and archival of manual and electronic drug safety files pertaining to ICSR management.Reviews the quality of outputs from the safety database (or provide if needed) for signal meetings, safety summaries for Investigator Brochures (IBs), Developmental / Periodic Safety Update Reports (D/ PSURs) and Annual Reports.Performs other tasks and assignments as needed and specified by management.   qualifications: BSN/RN, Bachelor's degree in Biological Sciences, Pharmacy or PharmD degree or equivalent and a minimum of 5 years of progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, including experience within pharmacovigilance operations.Demonstrated expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.Extensive, hands-on working knowledge of MedDRA terminology and the processing of AEs/SAEs in the pharmaceutical industry.Extensive experience of QC and workflow monitoring to ensure quality and timeliness of case processing.Demonstrated ability to identify opportunities to improve the PV reporting process(es).Ability to influence without direct authority.Proficiency with Microsoft Office.Excellent verbal and written communication and skills.Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. Preferred: Understanding of safety database administration, configuration, data entry and extraction, specifically with Argus.Expertise in the use of Electronic Document Management System (eDMS) software.Expertise in MedDRA and WHODD with relevance to coding suspect drug and concomitant medications.  skills: Argus, SAE (Serious Adverse Event), AD (Adverse Events), ICSR (Individual Case Study Report), MedDRA Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

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