Manager, Quality Control Sample Management in Devens, MA
Bristol-Myers Squibb
Manager, Quality Control Sample Management in Devens, MA
Job Description
Provide supervision of QC Sample Management shift and oversee the daily Sample Management activities related to in-process, final release and stability testing of cell therapy drug product. Develop and manage a daily work plan for QC associates. Report out quality and operational metrics. Responsible for management of QC samples and materials including chain of custody, label, receipt, storage, transfer, and disposal according to GMP requirements and approved procedures. Facilitate cold chain transfers of samples, as required. Hire, mentor and develop the team members to support the business operations and employee career development. Oversee the training of the team members. Review and approve procedures for Sample Management activities. Collaborate with other departments to identify and implement process improvements. Own and evaluate relevant change controls, investigations, deviations, CAPAs. Apply critical thinking skills when working on new procedures or process improvements. Communicate effectively with management regarding task completion, roadblocks, and needs. Perform other tasks as assigned. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Experience with cold chain sample storage and transfer in a GMP regulated environment. Familiar with Excel, Visio, Power Point, and other software systems. Experience with laboratory LIMS and ERP systems (e.g., SAP) preferred. Ability to work in a highly regulated environment and follow regulatory requirements and GMPs. Ability to mentor associates, manage multiple assignment while meeting timelines in a GMP environment. Advanced ability to work in a collaborative team environment and train others. Advanced ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Excellent organizational and critical thinking skills. Advanced ability to communicate effectively with peers, department management and cross-functional peers. Bachelor's degree required, preferably in Chemistry, Microbiology or related science. 6+ years of relevant work experience, preferable in a regulated environment. 2+ years of management and people leader experience. An equivalent combination of education and experience may substitute. The incumbent will be working around biohazardous materials. The incumbent may be exposed to fluctuating and/or extreme temperatures on occasion.
Key Responsibilities
- Provide supervision of QC Sample Management shift and oversee daily Sample Management activities related to in-process, final release, and stability testing of cell therapy drug product
- Develop and manage a daily work plan for QC associates
- Report out quality and operational metrics
- Responsible for management of QC samples and materials including chain of custody, label, receipt, storage, transfer, and disposal according to GMP requirements and approved procedures
- Facilitate cold chain transfers of samples, as required
- Hire, mentor, and develop team members to support business operations and employee career development
- Oversee the training of team members
- Review and approve procedures for Sample Management activities
- Collaborate with other departments to identify and implement process improvements
- Own and evaluate relevant change controls, investigations, deviations, CAPAs
- Apply critical thinking skills when working on new procedures or process improvements
- Communicate effectively with management regarding task completion, roadblocks, and needs
- Perform other tasks as assigned
Required Qualifications
- Bachelor's degree, preferably in Chemistry, Microbiology or related science
- + years of relevant work experience, preferable in a regulated environment
- + years of management and people leader experience
- An equivalent combination of education and experience may substitute
Preferred Qualifications
- Experience with laboratory LIMS and ERP systems (e.g., SAP)
Skills Required
- Experience with cold chain sample storage and transfer in a GMP regulated environment
- Familiarity with Excel, Visio, PowerPoint, and other software systems
- Ability to work in a highly regulated environment and follow regulatory requirements and GMPs
- Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment
- Advanced ability to work in a collaborative team environment and train others
- Advanced ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
- Excellent organizational and critical thinking skills
- Advanced ability to communicate effectively with peers, department management, and cross-functional peers
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Additional Requirements
- The incumbent will be working around biohazardous materials
- The incumbent may be exposed to fluctuating and/or extreme temperatures on occasion
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
90,000 - 130,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Experience with cold chain sample storage and transfer in a GMP regulated environmentintermediate
- Familiarity with Excel, Visio, PowerPoint, and other software systemsintermediate
- Ability to work in a highly regulated environment and follow regulatory requirements and GMPsintermediate
- Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environmentintermediate
- Advanced ability to work in a collaborative team environment and train othersintermediate
- Advanced ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projectsintermediate
- Excellent organizational and critical thinking skillsintermediate
- Advanced ability to communicate effectively with peers, department management, and cross-functional peersintermediate
Required Qualifications
- Bachelor's degree, preferably in Chemistry, Microbiology or related science (experience)
- + years of relevant work experience, preferable in a regulated environment (experience)
- + years of management and people leader experience (experience)
- An equivalent combination of education and experience may substitute (experience)
Preferred Qualifications
- Experience with laboratory LIMS and ERP systems (e.g., SAP) (experience)
Responsibilities
- Provide supervision of QC Sample Management shift and oversee daily Sample Management activities related to in-process, final release, and stability testing of cell therapy drug product
- Develop and manage a daily work plan for QC associates
- Report out quality and operational metrics
- Responsible for management of QC samples and materials including chain of custody, label, receipt, storage, transfer, and disposal according to GMP requirements and approved procedures
- Facilitate cold chain transfers of samples, as required
- Hire, mentor, and develop team members to support business operations and employee career development
- Oversee the training of team members
- Review and approve procedures for Sample Management activities
- Collaborate with other departments to identify and implement process improvements
- Own and evaluate relevant change controls, investigations, deviations, CAPAs
- Apply critical thinking skills when working on new procedures or process improvements
- Communicate effectively with management regarding task completion, roadblocks, and needs
- Perform other tasks as assigned
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
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Manager, Quality Control Sample Management in Devens, MA
Bristol-Myers Squibb
Manager, Quality Control Sample Management in Devens, MA
Job Description
Provide supervision of QC Sample Management shift and oversee the daily Sample Management activities related to in-process, final release and stability testing of cell therapy drug product. Develop and manage a daily work plan for QC associates. Report out quality and operational metrics. Responsible for management of QC samples and materials including chain of custody, label, receipt, storage, transfer, and disposal according to GMP requirements and approved procedures. Facilitate cold chain transfers of samples, as required. Hire, mentor and develop the team members to support the business operations and employee career development. Oversee the training of the team members. Review and approve procedures for Sample Management activities. Collaborate with other departments to identify and implement process improvements. Own and evaluate relevant change controls, investigations, deviations, CAPAs. Apply critical thinking skills when working on new procedures or process improvements. Communicate effectively with management regarding task completion, roadblocks, and needs. Perform other tasks as assigned. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Experience with cold chain sample storage and transfer in a GMP regulated environment. Familiar with Excel, Visio, Power Point, and other software systems. Experience with laboratory LIMS and ERP systems (e.g., SAP) preferred. Ability to work in a highly regulated environment and follow regulatory requirements and GMPs. Ability to mentor associates, manage multiple assignment while meeting timelines in a GMP environment. Advanced ability to work in a collaborative team environment and train others. Advanced ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Excellent organizational and critical thinking skills. Advanced ability to communicate effectively with peers, department management and cross-functional peers. Bachelor's degree required, preferably in Chemistry, Microbiology or related science. 6+ years of relevant work experience, preferable in a regulated environment. 2+ years of management and people leader experience. An equivalent combination of education and experience may substitute. The incumbent will be working around biohazardous materials. The incumbent may be exposed to fluctuating and/or extreme temperatures on occasion.
Key Responsibilities
- Provide supervision of QC Sample Management shift and oversee daily Sample Management activities related to in-process, final release, and stability testing of cell therapy drug product
- Develop and manage a daily work plan for QC associates
- Report out quality and operational metrics
- Responsible for management of QC samples and materials including chain of custody, label, receipt, storage, transfer, and disposal according to GMP requirements and approved procedures
- Facilitate cold chain transfers of samples, as required
- Hire, mentor, and develop team members to support business operations and employee career development
- Oversee the training of team members
- Review and approve procedures for Sample Management activities
- Collaborate with other departments to identify and implement process improvements
- Own and evaluate relevant change controls, investigations, deviations, CAPAs
- Apply critical thinking skills when working on new procedures or process improvements
- Communicate effectively with management regarding task completion, roadblocks, and needs
- Perform other tasks as assigned
Required Qualifications
- Bachelor's degree, preferably in Chemistry, Microbiology or related science
- + years of relevant work experience, preferable in a regulated environment
- + years of management and people leader experience
- An equivalent combination of education and experience may substitute
Preferred Qualifications
- Experience with laboratory LIMS and ERP systems (e.g., SAP)
Skills Required
- Experience with cold chain sample storage and transfer in a GMP regulated environment
- Familiarity with Excel, Visio, PowerPoint, and other software systems
- Ability to work in a highly regulated environment and follow regulatory requirements and GMPs
- Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environment
- Advanced ability to work in a collaborative team environment and train others
- Advanced ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
- Excellent organizational and critical thinking skills
- Advanced ability to communicate effectively with peers, department management, and cross-functional peers
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Additional Requirements
- The incumbent will be working around biohazardous materials
- The incumbent may be exposed to fluctuating and/or extreme temperatures on occasion
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
90,000 - 130,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Experience with cold chain sample storage and transfer in a GMP regulated environmentintermediate
- Familiarity with Excel, Visio, PowerPoint, and other software systemsintermediate
- Ability to work in a highly regulated environment and follow regulatory requirements and GMPsintermediate
- Ability to mentor associates, manage multiple assignments while meeting timelines in a GMP environmentintermediate
- Advanced ability to work in a collaborative team environment and train othersintermediate
- Advanced ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projectsintermediate
- Excellent organizational and critical thinking skillsintermediate
- Advanced ability to communicate effectively with peers, department management, and cross-functional peersintermediate
Required Qualifications
- Bachelor's degree, preferably in Chemistry, Microbiology or related science (experience)
- + years of relevant work experience, preferable in a regulated environment (experience)
- + years of management and people leader experience (experience)
- An equivalent combination of education and experience may substitute (experience)
Preferred Qualifications
- Experience with laboratory LIMS and ERP systems (e.g., SAP) (experience)
Responsibilities
- Provide supervision of QC Sample Management shift and oversee daily Sample Management activities related to in-process, final release, and stability testing of cell therapy drug product
- Develop and manage a daily work plan for QC associates
- Report out quality and operational metrics
- Responsible for management of QC samples and materials including chain of custody, label, receipt, storage, transfer, and disposal according to GMP requirements and approved procedures
- Facilitate cold chain transfers of samples, as required
- Hire, mentor, and develop team members to support business operations and employee career development
- Oversee the training of team members
- Review and approve procedures for Sample Management activities
- Collaborate with other departments to identify and implement process improvements
- Own and evaluate relevant change controls, investigations, deviations, CAPAs
- Apply critical thinking skills when working on new procedures or process improvements
- Communicate effectively with management regarding task completion, roadblocks, and needs
- Perform other tasks as assigned
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Manager, Quality Control Sample Management in Devens, MA @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs