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3 jobs found in swiftwater, pennsylvania

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    • swiftwater, pennsylvania
    • contract
    • $50 - $54.35 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: Swiftwater, Pennsylvania job type: Contract salary: $50.00 - 54.35 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Duties Candidate to author/review/approve CMC technical documents in company's internal document system to support regulatory submissions (may include BLA, MAA, IND, supplements) to US FDA and international Health Authorities.Must have working knowledge of biologic/drug regulations (FDA, ICH, EU, etc) related to CMC.Provide regulatory guidance for development projects, post-approval CMC changes/variations.Must have working knowledge of GMPs.Must be well-organized, work with minimal management and meet aggressive timelines.Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.**This position is working in the CMC area. Relevant experience is required.  qualifications: 4 year degree or higher - science preferred, but open to other backgrounds.2+ years of industry experience (regulatory preferred).Attention to detailGood communication.Writing skillsExperience working in electronic systems Skills CMC/ Regulatory writing experience - 3 + years authoring CMC regulatory documents including Module 2 and Module 2.3 Scientific background, vaccines preferredMicrosoft Office (word, excel, PowerPoint)Documentum/ Veeva Applications Trackwise Applications ICH GuidelinesGMP experience Experience with drug/biologics licensure preferred Prior regulatory experienceEducation BS in Biology/Chemistry or related field  skills: CMC, MS-WORD, MS-EXCEL, MS-Powerpoint, 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. 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: Swiftwater, Pennsylvania job type: Contract salary: $50.00 - 54.35 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Duties Candidate to author/review/approve CMC technical documents in company's internal document system to support regulatory submissions (may include BLA, MAA, IND, supplements) to US FDA and international Health Authorities.Must have working knowledge of biologic/drug regulations (FDA, ICH, EU, etc) related to CMC.Provide regulatory guidance for development projects, post-approval CMC changes/variations.Must have working knowledge of GMPs.Must be well-organized, work with minimal management and meet aggressive timelines.Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.**This position is working in the CMC area. Relevant experience is required.  qualifications: 4 year degree or higher - science preferred, but open to other backgrounds.2+ years of industry experience (regulatory preferred).Attention to detailGood communication.Writing skillsExperience working in electronic systems Skills CMC/ Regulatory writing experience - 3 + years authoring CMC regulatory documents including Module 2 and Module 2.3 Scientific background, vaccines preferredMicrosoft Office (word, excel, PowerPoint)Documentum/ Veeva Applications Trackwise Applications ICH GuidelinesGMP experience Experience with drug/biologics licensure preferred Prior regulatory experienceEducation BS in Biology/Chemistry or related field  skills: CMC, MS-WORD, MS-EXCEL, MS-Powerpoint, 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.
    • swiftwater, pennsylvania
    • temporary
    • $35 - $40 per hour
    The primary role of the successful group manager candidate will be to lead, coach and manage project managers and schedulers engaged by Sanofi Pasteur to facilitate the transition to a standardized project execution discipline. This requires experience managing projects in the pharmaceutical or biopharmaceutical arena. Understanding of relevant quality standards related to pharmaceutical supply chain: validation, equipment qualification, process validation, and drug substance manufacturing. Flexible with the ability to work well with large diverse groups in a matrixed, growing organization. salary: $35 - $40 per hourshift: Firstwork hours: 8 AM - 4 PMeducation: BachelorResponsibilitiesProject Management Responsibilities include: Initial Project Definition: Lead or co-lead project meetings on behalf of the project leader when necessary. Excellent communication skills. Ability to communicate with employees of all experience levels. Ability to report on project activity in a clear and concise manner. Ability to communicate project issues in a manner that to leads to resolution: Experience in managing and remediating project budgets Experience in executing projects at all phases of the project life cycle Expertise in MS Project or Primavera, Excel and Word,Sufficient financial understanding to facilitate the compilation and communication of project finances Bachelor's Degree/Undergraduate Degree in technical discipline with a PMP certificate strong relational leader who has the ability to establish working relationships with project team members, key customers and stakeholders. Ability to manage projects with challenging timelines SkillsProject ManagerPlanningQualificationsYears of experience: 5 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. 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.
    The primary role of the successful group manager candidate will be to lead, coach and manage project managers and schedulers engaged by Sanofi Pasteur to facilitate the transition to a standardized project execution discipline. This requires experience managing projects in the pharmaceutical or biopharmaceutical arena. Understanding of relevant quality standards related to pharmaceutical supply chain: validation, equipment qualification, process validation, and drug substance manufacturing. Flexible with the ability to work well with large diverse groups in a matrixed, growing organization. salary: $35 - $40 per hourshift: Firstwork hours: 8 AM - 4 PMeducation: BachelorResponsibilitiesProject Management Responsibilities include: Initial Project Definition: Lead or co-lead project meetings on behalf of the project leader when necessary. Excellent communication skills. Ability to communicate with employees of all experience levels. Ability to report on project activity in a clear and concise manner. Ability to communicate project issues in a manner that to leads to resolution: Experience in managing and remediating project budgets Experience in executing projects at all phases of the project life cycle Expertise in MS Project or Primavera, Excel and Word,Sufficient financial understanding to facilitate the compilation and communication of project finances Bachelor's Degree/Undergraduate Degree in technical discipline with a PMP certificate strong relational leader who has the ability to establish working relationships with project team members, key customers and stakeholders. Ability to manage projects with challenging timelines SkillsProject ManagerPlanningQualificationsYears of experience: 5 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. 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.
    • swiftwater, pennsylvania
    • contract
    • $34 - $38.83 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: Swiftwater, Pennsylvania job type: Contract salary: $34.00 - 38.83 per hour work hours: 9 to 5 education: Bachelors   responsibilities: The individual will review and approve qualification and validation related documentation for assigned areas including, but not limited to, User Requirements, Specifications, IOQs, PQs, for production and laboratory equipment.This position may have signatory responsibilities for qualifications/validation deliverables associated with assigned area(s).  qualifications: Bachelor's Degree/Undergraduate Degree in engineering or technical discipline. Master Degree preferred.Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment.Background in Validation and Quality background is needed. Experience reviewing and approving qualification related documentation preferred.Ability to work on strict deadlines.Ability to interface with cross-functional teams.Detail oriented.Ability to handle multiple projects concurrently.Strong working knowledge of Quality System RegulationsExperience leading CAPA (Corrective and Preventive Action) activities.Well-developed communication skills, both verbal and written.Years of Experience: 6 - 9 Years  skills: MS-WORD, CAPA, MS-EXCEL 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: Swiftwater, Pennsylvania job type: Contract salary: $34.00 - 38.83 per hour work hours: 9 to 5 education: Bachelors   responsibilities: The individual will review and approve qualification and validation related documentation for assigned areas including, but not limited to, User Requirements, Specifications, IOQs, PQs, for production and laboratory equipment.This position may have signatory responsibilities for qualifications/validation deliverables associated with assigned area(s).  qualifications: Bachelor's Degree/Undergraduate Degree in engineering or technical discipline. Master Degree preferred.Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment.Background in Validation and Quality background is needed. Experience reviewing and approving qualification related documentation preferred.Ability to work on strict deadlines.Ability to interface with cross-functional teams.Detail oriented.Ability to handle multiple projects concurrently.Strong working knowledge of Quality System RegulationsExperience leading CAPA (Corrective and Preventive Action) activities.Well-developed communication skills, both verbal and written.Years of Experience: 6 - 9 Years  skills: MS-WORD, CAPA, MS-EXCEL 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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