Bristol Myers Squibb
Senior Specialist, QC Microbiology, Cell Therapy
Bristol Myers Squibb, Summit, New Jersey, us, 07902
Senior Specialist, QC Microbiology, Cell Therapy
Senior Specialist, QC Microbiology, Cell Therapy will be responsible for supporting QC testing for in-process, final product, stability samples and for supporting environmental and facility monitoring, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts. Shift
Sunday - Wednesday, Onsite Overnight Shift, 4 p.m. - 2:30 a.m. Responsibilities
Perform method transfer/ verification/ validation, routine testing of in-process, final product, and stability samples. Perform environmental/facilities monitoring and microbiological testing. 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. Knowledge & Skills
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. Knowledge of LIMS, ELN and laboratory data analysis systems preferred. Basic Requirements
Bachelor's degree or equivalent required, preferably in science. An equivalent combination of higher education and experience will be considered. 4+ years of relevant microbiological testing or QC experience or Demonstrated experience with microbiological and aseptic techniques Working Conditions
Individual must be able to work in a laboratory environment. Able to problem solve with minimal supervision. Works in a team-based, cross-functional environment to complete tasks required by shift schedule. Other duties may be assigned, as necessary. Available to work OT when business requires. Willing to work staggered day shift hours. Compensation overview and additional company-specific information are listed on the careers site and may vary by location.
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Senior Specialist, QC Microbiology, Cell Therapy will be responsible for supporting QC testing for in-process, final product, stability samples and for supporting environmental and facility monitoring, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts. Shift
Sunday - Wednesday, Onsite Overnight Shift, 4 p.m. - 2:30 a.m. Responsibilities
Perform method transfer/ verification/ validation, routine testing of in-process, final product, and stability samples. Perform environmental/facilities monitoring and microbiological testing. 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. Knowledge & Skills
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. Knowledge of LIMS, ELN and laboratory data analysis systems preferred. Basic Requirements
Bachelor's degree or equivalent required, preferably in science. An equivalent combination of higher education and experience will be considered. 4+ years of relevant microbiological testing or QC experience or Demonstrated experience with microbiological and aseptic techniques Working Conditions
Individual must be able to work in a laboratory environment. Able to problem solve with minimal supervision. Works in a team-based, cross-functional environment to complete tasks required by shift schedule. Other duties may be assigned, as necessary. Available to work OT when business requires. Willing to work staggered day shift hours. Compensation overview and additional company-specific information are listed on the careers site and may vary by location.
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