Senior Specialist QC Analytical Cell Therapy - Devens MA
VetJobs, Harvard, Massachusetts, us, 01451
Overview
Senior Specialist, QC Analytical, Cell Therapy – On-Site at the location detailed in the job post. The organization sources qualified talent for open roles with partner companies and invites applicants including Veterans, transitioning military, National Guard and Reserve Members, military spouses, wounded warriors, and their caregivers. Position
Senior Specialist, QC Analytical, Cell Therapy Position Summary
Responsible for supporting QC testing for in-process, final product, and stability samples, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts. Key Responsibilities
Perform method transfer/validation and routine testing of in-process, final product, and stability samples. Anticipate and perform routine troubleshooting and problem solving with minimal guidance. Perform data verification, data review and review of GMP documentation for general and complex methods. Perform document revision, project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts. Train and mentor others on QC test methods, processes and procedures. Perform other tasks as assigned. Auto req ID
463734BR Education & Experience
Minimum Education Required: Bachelors Job Category
Management Additional Qualifications/Responsibilities
Qualifications & Experience: Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Demonstrated technical writing skills. High problem-solving ability/mentality, technically adept and logical. Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs. Ability to work in a fast-paced team environment, meet deadlines, and prioritize work. Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred. Education / Experience / Licenses / Certifications
Bachelor's degree or equivalent required, preferably in science. Netherlands: Bachelor's degree / HLO in (bioanalytical) science required. 4+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment. Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique). Compensation Overview
Devens, MA, US: $43.84 - $53.12 per hour City: Devens State: Massachusetts Job Code: Pharmaceutical Pharmaceutical Affiliate Sponsor: Bristol Myers Squibb (BMS) Salary Range: >$100,000
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Senior Specialist, QC Analytical, Cell Therapy – On-Site at the location detailed in the job post. The organization sources qualified talent for open roles with partner companies and invites applicants including Veterans, transitioning military, National Guard and Reserve Members, military spouses, wounded warriors, and their caregivers. Position
Senior Specialist, QC Analytical, Cell Therapy Position Summary
Responsible for supporting QC testing for in-process, final product, and stability samples, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts. Key Responsibilities
Perform method transfer/validation and routine testing of in-process, final product, and stability samples. Anticipate and perform routine troubleshooting and problem solving with minimal guidance. Perform data verification, data review and review of GMP documentation for general and complex methods. Perform document revision, project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts. Train and mentor others on QC test methods, processes and procedures. Perform other tasks as assigned. Auto req ID
463734BR Education & Experience
Minimum Education Required: Bachelors Job Category
Management Additional Qualifications/Responsibilities
Qualifications & Experience: Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Demonstrated technical writing skills. High problem-solving ability/mentality, technically adept and logical. Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs. Ability to work in a fast-paced team environment, meet deadlines, and prioritize work. Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred. Education / Experience / Licenses / Certifications
Bachelor's degree or equivalent required, preferably in science. Netherlands: Bachelor's degree / HLO in (bioanalytical) science required. 4+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment. Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique). Compensation Overview
Devens, MA, US: $43.84 - $53.12 per hour City: Devens State: Massachusetts Job Code: Pharmaceutical Pharmaceutical Affiliate Sponsor: Bristol Myers Squibb (BMS) Salary Range: >$100,000
#J-18808-Ljbffr