Bristol Myers Squibb
Senior Specialist, QC Compliance, Cell Therapy
Bristol Myers Squibb, Summit, New Jersey, us, 07902
Overview
Senior Specialist, QC Compliance, Cell Therapy – Bristol Myers Squibb. The Senior Specialist, QC Compliance is responsible for leading QC deviation, laboratory investigations, CAPAs and change control. Responsibilities
Lead and author QC deviation, laboratory investigations, CAPAs and change control. Work with QC SMEs to conduct root cause analysis. Ensure timely and compliant closure of investigations, deviations, CAPAs and change controls. Perform document revision, project, CAPA and deviation/ investigation, change mgmt. actions, related tasks and/ or continuous improvement efforts. Train and mentor others on deviation, investigation, CAPA and change control process/ procedures. May support health agency inspection as equipment area subject matter expert. Knowledge & Skills
Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. High problem-solving ability/mentality, critical thinking, 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, action oriented, highly organized to meet deadlines and prioritize work. Knowledge of cell therapy analytical and microbiological testing. Demonstrated experience with Quality management systems. Demonstrated technical writing skills. Demonstrated experience in laboratory or biomanufacturing. Investigations and root cause analysis techniques. Basic Requirements
Bachelor's degree in science, engineering, or related discipline. An equivalent combination of higher education and experience will be considered. 4+ years of experience in QC lab operations. 2+ years of prior deviation/investigation experience required. 1 year of QC Microbiology lab experience. Preferred Requirements
Previous CT experience. Shift & Location
Shift Available: Sunday - Wednesday, Hybrid Day Shift 8 a.m. - 6 p.m. Location: Summit West, NJ, US Compensation & Benefits
The starting compensation range for this role is listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. Eligibility for specific benefits varies by job and location. Equal Opportunity
BMS is an equal opportunity employer. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require accommodations, contact adastaffingsupport@bms.com. For more details, visit careers.bms.com/eeo-accessibility.
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Senior Specialist, QC Compliance, Cell Therapy – Bristol Myers Squibb. The Senior Specialist, QC Compliance is responsible for leading QC deviation, laboratory investigations, CAPAs and change control. Responsibilities
Lead and author QC deviation, laboratory investigations, CAPAs and change control. Work with QC SMEs to conduct root cause analysis. Ensure timely and compliant closure of investigations, deviations, CAPAs and change controls. Perform document revision, project, CAPA and deviation/ investigation, change mgmt. actions, related tasks and/ or continuous improvement efforts. Train and mentor others on deviation, investigation, CAPA and change control process/ procedures. May support health agency inspection as equipment area subject matter expert. Knowledge & Skills
Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. High problem-solving ability/mentality, critical thinking, 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, action oriented, highly organized to meet deadlines and prioritize work. Knowledge of cell therapy analytical and microbiological testing. Demonstrated experience with Quality management systems. Demonstrated technical writing skills. Demonstrated experience in laboratory or biomanufacturing. Investigations and root cause analysis techniques. Basic Requirements
Bachelor's degree in science, engineering, or related discipline. An equivalent combination of higher education and experience will be considered. 4+ years of experience in QC lab operations. 2+ years of prior deviation/investigation experience required. 1 year of QC Microbiology lab experience. Preferred Requirements
Previous CT experience. Shift & Location
Shift Available: Sunday - Wednesday, Hybrid Day Shift 8 a.m. - 6 p.m. Location: Summit West, NJ, US Compensation & Benefits
The starting compensation range for this role is listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. Eligibility for specific benefits varies by job and location. Equal Opportunity
BMS is an equal opportunity employer. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require accommodations, contact adastaffingsupport@bms.com. For more details, visit careers.bms.com/eeo-accessibility.
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