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    • minneapolis, minnesota
    • contract
    • $28.64 - $33.67 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. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation. 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: Minneapolis, Minnesota job type: Contract salary: $28.64 - 33.67 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Perform Quality Systems activities associated with commercial cGMP biologics drug substance manufactured at Takeda Brooklyn Park.Serve as the primary Business Administrator and Subject Matter Expert (SME) for company's Electronic Quality Management System.Support quality management procedures and provide targeted technical training (e.g., deviation, CAPA, change management).Drive on-time completion of deviations, CAPAs and change requests with metrics reporting and cross-functional interaction.Report metrics on health of the business as it relates to Quality Systems.Provide assistance to site personnel performing deviation investigations, CAPAs, and change controls.Performs documentation review thoroughly, with a high attention to detail, using working knowledge of quality concepts and internal procedures and controls.Supports GMP compliance with time spent in the Manufacturing environment on a regular basis.Analyzes and interprets projects, studies, or investigations to determine next steps in consultation with management. Makes basic decisions independently. Reviews more complex decisions with management.Identifies and resolves basic technical issues using problem-solving skills, in consultation with management.Assesses deviations assigned a direct root cause, defined CAPAs, and entry-level change controls.Revises department-specific controlled documents independently.Receives minimal supervision on routine work assignments. Receives specific instruction on new assignments.Identifies and proposes Quality Process and system improvements.Complete mandatory training within required timeframe.Performs additional duties, as assigned, including support of Compliance and Supplier Quality functions.  qualifications: BA/BS (or Master's) in any Life Science discipline preferred, and/or 3-5 years' experience in Regulated (food, medical device, or pharma/biotech) industry.Understands and applies good working knowledge of quality and GMP principles.Familiarity or experience with the following is preferred: DMAIC investigation process; Root Cause Analysis; basic statistics; Peer review/approval of documentation; Quality Training; Quality Improvement Tools (Risk Assessments, flowcharts, metrics generation); Technical Writing and Review; Writing/reviewing/approving investigationsAbility to handle tasks concurrently and use productivity tools to meet deadlines.Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers, and management.Must be able to read, write and converse in English.Must display eagerness to learn and continuously improve.Positive work attitude, including the values of Takeda-ism (honesty, integrity, perseverance, and fairness) that support teamwork and professionalism.Must be experienced in Microsoft Office applications, especially Word, Excel, and PowerPoint.ASQ Certified Quality Auditor (CQA) or other certification, a plus.Stand or sit -? Must be able to remain in a stationary or standing position for extended periods of time.Wrist and hand motion (e.g., typing, writing)Must be able to work in controlled or clean room environments requiring special gowning.Other / Travel Requirements:May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.May be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department.Willingness to travel to various meetings or training, this could include overnight trips.Requires approximately 5% travel.  skills: Quality control, Quality Assurance, CAPA, 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.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. 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. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation. 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: Minneapolis, Minnesota job type: Contract salary: $28.64 - 33.67 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Perform Quality Systems activities associated with commercial cGMP biologics drug substance manufactured at Takeda Brooklyn Park.Serve as the primary Business Administrator and Subject Matter Expert (SME) for company's Electronic Quality Management System.Support quality management procedures and provide targeted technical training (e.g., deviation, CAPA, change management).Drive on-time completion of deviations, CAPAs and change requests with metrics reporting and cross-functional interaction.Report metrics on health of the business as it relates to Quality Systems.Provide assistance to site personnel performing deviation investigations, CAPAs, and change controls.Performs documentation review thoroughly, with a high attention to detail, using working knowledge of quality concepts and internal procedures and controls.Supports GMP compliance with time spent in the Manufacturing environment on a regular basis.Analyzes and interprets projects, studies, or investigations to determine next steps in consultation with management. Makes basic decisions independently. Reviews more complex decisions with management.Identifies and resolves basic technical issues using problem-solving skills, in consultation with management.Assesses deviations assigned a direct root cause, defined CAPAs, and entry-level change controls.Revises department-specific controlled documents independently.Receives minimal supervision on routine work assignments. Receives specific instruction on new assignments.Identifies and proposes Quality Process and system improvements.Complete mandatory training within required timeframe.Performs additional duties, as assigned, including support of Compliance and Supplier Quality functions.  qualifications: BA/BS (or Master's) in any Life Science discipline preferred, and/or 3-5 years' experience in Regulated (food, medical device, or pharma/biotech) industry.Understands and applies good working knowledge of quality and GMP principles.Familiarity or experience with the following is preferred: DMAIC investigation process; Root Cause Analysis; basic statistics; Peer review/approval of documentation; Quality Training; Quality Improvement Tools (Risk Assessments, flowcharts, metrics generation); Technical Writing and Review; Writing/reviewing/approving investigationsAbility to handle tasks concurrently and use productivity tools to meet deadlines.Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers, and management.Must be able to read, write and converse in English.Must display eagerness to learn and continuously improve.Positive work attitude, including the values of Takeda-ism (honesty, integrity, perseverance, and fairness) that support teamwork and professionalism.Must be experienced in Microsoft Office applications, especially Word, Excel, and PowerPoint.ASQ Certified Quality Auditor (CQA) or other certification, a plus.Stand or sit -? Must be able to remain in a stationary or standing position for extended periods of time.Wrist and hand motion (e.g., typing, writing)Must be able to work in controlled or clean room environments requiring special gowning.Other / Travel Requirements:May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.May be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department.Willingness to travel to various meetings or training, this could include overnight trips.Requires approximately 5% travel.  skills: Quality control, Quality Assurance, CAPA, 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.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. 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.
    • minneapolis, minnesota
    • temp to perm
    • $18 - $23.58 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. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you! 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: Minneapolis, Minnesota job type: Temporary salary: $18.00 - 23.58 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Perform and document daily manufacturing operations according to SOPs in a cGMP environmentOperate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels) Execute validation protocolsCreate or revise cGMP documentsWith general supervision or guidance will assemble and/or operate biologics production equipment, such as bioreactors, filtration units, chromatography systems and fixed/portable vessels. Perform basic trouble shooting Performs/assists with processing steps and/or manufacturing support activities by monitoring process parameters in batch record and control systemsDocuments cGMP data and information for processing steps and/or equipment activities while following standard operating procedures.Key documentation includes batch records, work orders, and equipment logbooks. Executes batch records and validation protocols under supervision/direction of othersAuthor and review equipment use logsPerforms inventory transactions in SAP Performs data entry into LIMSAccountable for completing assigned trainings within required timeline and actively participate in training activities.Stock production and cleaning suppliesPerform cleaning/sanitizing production rooms and equipmentOther duties as assigned   qualifications: Bachelor's degree in Science or Engineering; or Associate's degree in science-related area and 1 or more years of relevant experience; or High school diploma or GED and 3 or more years of relevant experience. Experience in a regulated environment preferred Knowledge, competencies and skills: Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) preferredFamiliar or experience with cGMP within Biotech or Pharmaceutical operations preferred Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management a plusPrior experience with lab equipment a plusKnowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.Must have excellent written and oral communication skillsMust be team and detail-oriented and able to work in a fast-paced environment.Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web Based Training (WBT)Must be able to read and understand English PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position). Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time dailyCarrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day for 15-minute durations while handling production equipment and/or materialsClimb - Required to climb (use of stepladders/stairs in production areas, or stairwells in work campus) several times a day for 15-minute durations.Bend and Kneel - Required to bend, kneel, or crawl several times a day for 15-minute durationsOverhead work - Required to perform overhead reaching during handling of production materials/files/supplies several times a day for 15-minute durationsMoving Head and Neck- Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day for several hours at a timeTwisting - Required movement of twisting waist while setting up equipment several times a day for several hours at a timeRepetitive Use - Required repetitive use of arms and wrists while setting up equipment several times a day for several hours at a time OTHER REQUIREMENTS: Must have the ability to work assigned shift (day or night)Will be required to wear personal protective equipment (PPE) and other clean room garments daily.This may include: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protectionOn rare occasions, travel may be required to offsite meetings or training event  skills: SOP, Laboratory Information Management Systems (LIMS) 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. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you! 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: Minneapolis, Minnesota job type: Temporary salary: $18.00 - 23.58 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Perform and document daily manufacturing operations according to SOPs in a cGMP environmentOperate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels) Execute validation protocolsCreate or revise cGMP documentsWith general supervision or guidance will assemble and/or operate biologics production equipment, such as bioreactors, filtration units, chromatography systems and fixed/portable vessels. Perform basic trouble shooting Performs/assists with processing steps and/or manufacturing support activities by monitoring process parameters in batch record and control systemsDocuments cGMP data and information for processing steps and/or equipment activities while following standard operating procedures.Key documentation includes batch records, work orders, and equipment logbooks. Executes batch records and validation protocols under supervision/direction of othersAuthor and review equipment use logsPerforms inventory transactions in SAP Performs data entry into LIMSAccountable for completing assigned trainings within required timeline and actively participate in training activities.Stock production and cleaning suppliesPerform cleaning/sanitizing production rooms and equipmentOther duties as assigned   qualifications: Bachelor's degree in Science or Engineering; or Associate's degree in science-related area and 1 or more years of relevant experience; or High school diploma or GED and 3 or more years of relevant experience. Experience in a regulated environment preferred Knowledge, competencies and skills: Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) preferredFamiliar or experience with cGMP within Biotech or Pharmaceutical operations preferred Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management a plusPrior experience with lab equipment a plusKnowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.Must have excellent written and oral communication skillsMust be team and detail-oriented and able to work in a fast-paced environment.Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web Based Training (WBT)Must be able to read and understand English PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position). Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time dailyCarrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day for 15-minute durations while handling production equipment and/or materialsClimb - Required to climb (use of stepladders/stairs in production areas, or stairwells in work campus) several times a day for 15-minute durations.Bend and Kneel - Required to bend, kneel, or crawl several times a day for 15-minute durationsOverhead work - Required to perform overhead reaching during handling of production materials/files/supplies several times a day for 15-minute durationsMoving Head and Neck- Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day for several hours at a timeTwisting - Required movement of twisting waist while setting up equipment several times a day for several hours at a timeRepetitive Use - Required repetitive use of arms and wrists while setting up equipment several times a day for several hours at a time OTHER REQUIREMENTS: Must have the ability to work assigned shift (day or night)Will be required to wear personal protective equipment (PPE) and other clean room garments daily.This may include: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protectionOn rare occasions, travel may be required to offsite meetings or training event  skills: SOP, Laboratory Information Management Systems (LIMS) 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.
    • madison, wisconsin
    • permanent
    • $97,000 - $97,500 per year
    job summary: OUR TEAM: We are a motivated and caring team of individuals that support one another in providing quality assurance to existing products and new product development. We do this by partnering with our colleagues throughout the Promega organization, including Manufacturing, Quality Control, Research and Development, Marketing, Quality Systems, Technical Services, and others. JOB OBJECTIVE: Through their specified review, approval, and planning roles, QA Scientists apply their technical and quality system knowledge to assure internal and external customers that:   location: Madison, Wisconsin job type: Permanent salary: $97,000 - 97,500 per year work hours: 9 to 5 education: Bachelors   responsibilities: 1. Promega catalog and custom products meet their predetermined performance, process, and system requirements for quality. 2. Product and Process Changes and Quarantine disposition plans are implemented according to established procedures. 3. Technical literature (PPIs, labels, Technical Bulletins etc) are accurate and consistent. 4. Product performance claims and release criteria are based on objective data analysis. CORE DUTIES: Note that the emphasis placed on the essential duties listed here will vary by individual, depending on the focus and balance of that person's specific responsibilities. 1. Audit, data review, and approve product batch records for the next manufacturing step or availability in inventory. 2. Review and approve Manufacturing and Quality Control Protocols for catalog and custom products. 3. Review and approve product labels. 4. Establish and approve shelf-life assignments for catalog and custom products in cooperation with Manufacturing, Marketing, Regulatory Affairs and R&D staff. This includes approval of study design, data review, and change approval. 5. Review and approval of Technical Bulletins and Technical Manuals (performance and application claim accuracy and validity), including final release for publication. 6. Review and approve Promega Product Information (PPI) specification sheets and Certificates of Analysis; initiation, completion and issuance of these documents as required for custom products and some catalog products. 7. Assess the scope and inventory impact of nonconforming product situations; approving disposition plans of inventory product under quarantine; assisting in the disposition planning for nonconforming product in branch inventories. 8. Assist in the preparation, review and approval of design control documents. 9. Initiate, implement, review and/or approve Product and Process Change Plans. 10. Review, implement, and/or participate in Corrective and Preventive Action plans. 11. Review, implement, and participate in product and process validation planning. 12. Review, implement, and participate in complaint investigation planning. 13. Participate in process mapping and SOP development as directed. 14. Write SOPs as assigned. 15. Participate in team meetings to resolve planning and technical issues. Propose constructive solutions to existing problems. 16. Evaluate risks based on customer, technical, business and regulatory factors, provide options and recommendations to mitigate risk. 17. Consider basic regulatory requirements in product or process issues. 18. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others. 19. Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work. 20. Understand and comply with ethical, legal and regulatory requirements applicable to our business. OCCASIONAL DUTIES: 1. Organize, facilitate, or lead meetings to discuss review findings and planning issues. 2. Represent Promega in support of technical sales at national and international trade shows and exhibitions, or attend relevant scientific meetings as requested. 3. Contact customers directly about quality issues or questions as directed. 4. Organize and implement training programs in areas of expertise and experience. 5. Participate in continuous improvement projects.   qualifications: KEY QUALIFICATIONS: 1. B.S. degree with a minimum of 7 years work experience in a relevant industry with quality control, quality assurance, or manufacturing responsibilities. 2. Working knowledge and direct application experience of the requirements of quality assurance systems in a manufacturing and/or product development or process development environment. 3. Proficiency with basic word processing and spreadsheet software programs. 4. Ability to apply basic statistical concepts to analytical data, process validation, and Quality Assurance activities. 5. A demonstrable track record of process improvement and effective procedure writing and revision. 6. Able to develop concise, clear and accurate written communication. 7. Proven ability to work constructively with a broad range of people. PREFERRED QUALIFICATIONS: 1. In-depth technical knowledge in genomics, protein analysis, or cellular analysis evidenced by peer-reviewed publications. 2. Work experience in Quality Assurance from a regulated industry. PHYSICAL DEMANDS: 1. Visual acuity required for physical inspection of finished product and raw materials and accompanying documentation. 2. Ability to wear basic safety apparel (safety glasses or goggles, lab coats, protective gloves). 3. Ability to use computers in an interactive manner for extended periods of time.   skills: Biology, Chemistry, 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: OUR TEAM: We are a motivated and caring team of individuals that support one another in providing quality assurance to existing products and new product development. We do this by partnering with our colleagues throughout the Promega organization, including Manufacturing, Quality Control, Research and Development, Marketing, Quality Systems, Technical Services, and others. JOB OBJECTIVE: Through their specified review, approval, and planning roles, QA Scientists apply their technical and quality system knowledge to assure internal and external customers that:   location: Madison, Wisconsin job type: Permanent salary: $97,000 - 97,500 per year work hours: 9 to 5 education: Bachelors   responsibilities: 1. Promega catalog and custom products meet their predetermined performance, process, and system requirements for quality. 2. Product and Process Changes and Quarantine disposition plans are implemented according to established procedures. 3. Technical literature (PPIs, labels, Technical Bulletins etc) are accurate and consistent. 4. Product performance claims and release criteria are based on objective data analysis. CORE DUTIES: Note that the emphasis placed on the essential duties listed here will vary by individual, depending on the focus and balance of that person's specific responsibilities. 1. Audit, data review, and approve product batch records for the next manufacturing step or availability in inventory. 2. Review and approve Manufacturing and Quality Control Protocols for catalog and custom products. 3. Review and approve product labels. 4. Establish and approve shelf-life assignments for catalog and custom products in cooperation with Manufacturing, Marketing, Regulatory Affairs and R&D staff. This includes approval of study design, data review, and change approval. 5. Review and approval of Technical Bulletins and Technical Manuals (performance and application claim accuracy and validity), including final release for publication. 6. Review and approve Promega Product Information (PPI) specification sheets and Certificates of Analysis; initiation, completion and issuance of these documents as required for custom products and some catalog products. 7. Assess the scope and inventory impact of nonconforming product situations; approving disposition plans of inventory product under quarantine; assisting in the disposition planning for nonconforming product in branch inventories. 8. Assist in the preparation, review and approval of design control documents. 9. Initiate, implement, review and/or approve Product and Process Change Plans. 10. Review, implement, and/or participate in Corrective and Preventive Action plans. 11. Review, implement, and participate in product and process validation planning. 12. Review, implement, and participate in complaint investigation planning. 13. Participate in process mapping and SOP development as directed. 14. Write SOPs as assigned. 15. Participate in team meetings to resolve planning and technical issues. Propose constructive solutions to existing problems. 16. Evaluate risks based on customer, technical, business and regulatory factors, provide options and recommendations to mitigate risk. 17. Consider basic regulatory requirements in product or process issues. 18. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others. 19. Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work. 20. Understand and comply with ethical, legal and regulatory requirements applicable to our business. OCCASIONAL DUTIES: 1. Organize, facilitate, or lead meetings to discuss review findings and planning issues. 2. Represent Promega in support of technical sales at national and international trade shows and exhibitions, or attend relevant scientific meetings as requested. 3. Contact customers directly about quality issues or questions as directed. 4. Organize and implement training programs in areas of expertise and experience. 5. Participate in continuous improvement projects.   qualifications: KEY QUALIFICATIONS: 1. B.S. degree with a minimum of 7 years work experience in a relevant industry with quality control, quality assurance, or manufacturing responsibilities. 2. Working knowledge and direct application experience of the requirements of quality assurance systems in a manufacturing and/or product development or process development environment. 3. Proficiency with basic word processing and spreadsheet software programs. 4. Ability to apply basic statistical concepts to analytical data, process validation, and Quality Assurance activities. 5. A demonstrable track record of process improvement and effective procedure writing and revision. 6. Able to develop concise, clear and accurate written communication. 7. Proven ability to work constructively with a broad range of people. PREFERRED QUALIFICATIONS: 1. In-depth technical knowledge in genomics, protein analysis, or cellular analysis evidenced by peer-reviewed publications. 2. Work experience in Quality Assurance from a regulated industry. PHYSICAL DEMANDS: 1. Visual acuity required for physical inspection of finished product and raw materials and accompanying documentation. 2. Ability to wear basic safety apparel (safety glasses or goggles, lab coats, protective gloves). 3. Ability to use computers in an interactive manner for extended periods of time.   skills: Biology, Chemistry, 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.
    • grand island, new york
    • contract
    • $15 - $19.29 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: Grand Island, New York job type: Contract salary: $15.00 - 19.29 per hour work hours: 9 to 5 education: High School   responsibilities: Prints Inspection Instruction and Sample Drawing Instruction from SAP.Perform accurate review of incoming SAP printouts and vendor certificates for all components, labeling material and miscellaneous operating supply items.Utilizes SAP operating system to release the physical samples for testing.Performs routine testing of components, labeling, and miscellaneous items by visual/dimensional AQL assessment, using manual and/or automated methods.Qualifies as a visual inspector, subject to ongoing qualification testing/training.Maintains accurate documentation of all tracking and entries into applicable logbooks.Inspects vendor labels, contents and expiration dates to ensure results meet specifications.Samples glass shrinks as required for IQC testing.Obtain and delivers component samples to Microbiology and Chemistry for testing. Logs the samples onto the IQC Laboratory Testing log book, Microbiology and Chemistry log book.Utilizes SAP operating system to record results for miscellaneous supply items and performs physical release.Responsible for collecting all the data for Inter Location Transfers (ILT).Addresses any incoming quality issues with management and purchasing to resolve discrepancies in documentation or packaging utilizing SOP's and MCS's.Maintains the Monthly/Annual Departmental Log Book Reviews.Individual must use judgment to determine when independent action is appropriate or to contact supervisor for directionDuties are of routine nature and are followed according to established standard operating procedures.Assumes additional duties and responsibilities as assigned.Reports to the IQC/QC Chemistry Supervisor.  qualifications: Detailed oriented.Ability to perform light to moderate physical laborExcellent verbal and written communication skills are essentialAssociates degree with 1 - 2 years of related experienceHigh school diploma with 3+ years of related experience.Computer knowledge is desired.Must be able to work overtime as necessary.Working knowledge of cGMP's.  skills: Quality control, SOP, 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.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. 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: Grand Island, New York job type: Contract salary: $15.00 - 19.29 per hour work hours: 9 to 5 education: High School   responsibilities: Prints Inspection Instruction and Sample Drawing Instruction from SAP.Perform accurate review of incoming SAP printouts and vendor certificates for all components, labeling material and miscellaneous operating supply items.Utilizes SAP operating system to release the physical samples for testing.Performs routine testing of components, labeling, and miscellaneous items by visual/dimensional AQL assessment, using manual and/or automated methods.Qualifies as a visual inspector, subject to ongoing qualification testing/training.Maintains accurate documentation of all tracking and entries into applicable logbooks.Inspects vendor labels, contents and expiration dates to ensure results meet specifications.Samples glass shrinks as required for IQC testing.Obtain and delivers component samples to Microbiology and Chemistry for testing. Logs the samples onto the IQC Laboratory Testing log book, Microbiology and Chemistry log book.Utilizes SAP operating system to record results for miscellaneous supply items and performs physical release.Responsible for collecting all the data for Inter Location Transfers (ILT).Addresses any incoming quality issues with management and purchasing to resolve discrepancies in documentation or packaging utilizing SOP's and MCS's.Maintains the Monthly/Annual Departmental Log Book Reviews.Individual must use judgment to determine when independent action is appropriate or to contact supervisor for directionDuties are of routine nature and are followed according to established standard operating procedures.Assumes additional duties and responsibilities as assigned.Reports to the IQC/QC Chemistry Supervisor.  qualifications: Detailed oriented.Ability to perform light to moderate physical laborExcellent verbal and written communication skills are essentialAssociates degree with 1 - 2 years of related experienceHigh school diploma with 3+ years of related experience.Computer knowledge is desired.Must be able to work overtime as necessary.Working knowledge of cGMP's.  skills: Quality control, SOP, 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.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. 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.
    • north billerica, massachusetts
    • permanent
    • $82,000 - $130,000 per year
    This role will serve as primary lead for all aspects of Building Automation design, installation, commissioning, qualification, and validation projects, in addition to, daily operation, in-field troubleshooting, hands-on repair and maintenance of these systems and components. This position will also be responsible for system ownership and administration responsibilities for facilities-based monitoring systems, site wide 24/7 alarm system, energy monitoring system, and environmental condition monitoring system.  The ideal candidate will also possess PLC experience and technical skills associated with integration with building automation systems and components.salary: $82,000 - $130,000 per yearshift: Firstwork hours: 8 AM - 5 PMeducation: BachelorResponsibilities A Bachelor’s Degree in Electrical Engineering or related discipline preferred. Minimum of 7 years’ experience with Building Automation Systems, including commissioning, documentation, validation, maintenance, change control, and performance benchmarking of facility and manufacturing systems.  Experience in a pharmaceutical / life sciences environment preferred. Proficiency in the programming and troubleshooting of Building Automation Systems and instrumentation/electronic systems.  Significant Johnson Controls experience required.  Demonstrated proficiency in computerized maintenance management systems (CMMS).  Maximo experience a plus. Excellent leadership, organizational and time management skills. strong oral & written communication skills; ability to develop technical presentation materials. Demonstrated working knowledge of MS Office, BAS/BMS and PLC based systems required. Ability to lift forty (40) pounds on a regular basis, and ability to work at heights and in mechanical sp SkillsElectrical Engineering (1 year of experience is required)Building Automation Systems (1 year of experience is required)CMMS (1 year of experience is required)GMPPharmaceutical (1 year of experience is required)QualificationsYears of experience: 7 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. 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.
    This role will serve as primary lead for all aspects of Building Automation design, installation, commissioning, qualification, and validation projects, in addition to, daily operation, in-field troubleshooting, hands-on repair and maintenance of these systems and components. This position will also be responsible for system ownership and administration responsibilities for facilities-based monitoring systems, site wide 24/7 alarm system, energy monitoring system, and environmental condition monitoring system.  The ideal candidate will also possess PLC experience and technical skills associated with integration with building automation systems and components.salary: $82,000 - $130,000 per yearshift: Firstwork hours: 8 AM - 5 PMeducation: BachelorResponsibilities A Bachelor’s Degree in Electrical Engineering or related discipline preferred. Minimum of 7 years’ experience with Building Automation Systems, including commissioning, documentation, validation, maintenance, change control, and performance benchmarking of facility and manufacturing systems.  Experience in a pharmaceutical / life sciences environment preferred. Proficiency in the programming and troubleshooting of Building Automation Systems and instrumentation/electronic systems.  Significant Johnson Controls experience required.  Demonstrated proficiency in computerized maintenance management systems (CMMS).  Maximo experience a plus. Excellent leadership, organizational and time management skills. strong oral & written communication skills; ability to develop technical presentation materials. Demonstrated working knowledge of MS Office, BAS/BMS and PLC based systems required. Ability to lift forty (40) pounds on a regular basis, and ability to work at heights and in mechanical sp SkillsElectrical Engineering (1 year of experience is required)Building Automation Systems (1 year of experience is required)CMMS (1 year of experience is required)GMPPharmaceutical (1 year of experience is required)QualificationsYears of experience: 7 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. 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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