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Senior Specialist, Field Quality QA OperationsBristol-Myers Squibb • Harvard, Illinois, United States
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Senior Specialist, Field Quality QA Operations

Bristol-Myers Squibb
  • US
    Harvard, Illinois, United States
  • US
    Harvard, Illinois, United States
Apply Now

About

Summary This position is critical to maintaining quality oversight and ensuring GMP compliance in day‑to‑day manufacturing operations. The Senior Field QA Specialist reviews Manufacturing Batch Records (MBRs), conducts real‑time on‑floor exception reviews and logbooks, performs GMP area walkthroughs, and supports return‑to‑service (RTS) walkthroughs to confirm equipment readiness for production. Responsibilities Provide floor support for complex manufacturing activities. Review manufacturing batch production records to support product release in accordance with specifications and SOPs. Perform walkthroughs of GMP areas, documenting observations and areas of concern. Provide training on routine facility quality tasks for new team members. Support return‑to‑service walkthroughs and manufacturing inspection readiness per procedures as needed. Ensure all electronic and paper documentation requiring QA review complies with corporate, site procedures, cGMP regulations, and industry guidelines. Knowledge & Skills Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable. Knowledge of US and EU cGMP regulations and guidance. Knowledge of electronic or paper batch record systems, DeltaV, and other electronic systems relevant to laboratory test result generation, inventory management, investigations, equipment tracking, and maintenance. Basic Requirements Bachelor’s degree in science, engineering, biochemistry or a related discipline (or equivalent) is preferred. Four years of Quality Assurance experience within the pharmaceutical or medical device industry. Experience reviewing batch records. Experience working in a modern manufacturing facility with awareness of workplace standards, including pressurized liquids, gases, steam, and hazardous chemicals. Working Conditions Work is primarily performed in a modern manufacturing facility. Workers must use personal protective equipment (PPE) and appropriate gowning for clean‑room environments. The role involves exposure to pressurized liquids, gases, steam, and hazardous chemicals. Compensation Overview Devens, MA: $89,530 – $108,490 annually for a full‑time employee. Additional incentive cash and stock opportunities may be available based on eligibility. Benefits Health coverage: medical, pharmacy, dental and vision care. Well‑being support: programs such as BMS Well‑Being Account and Employee Assistance Programs. Financial protection: 401(k), disability, life insurance, supplemental health insurance, travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work‑life benefits: paid time off, flexible time off, unpaid volunteer days, summer hours flexibility and other leave options. Global shutdown: paid shutdown from Christmas to New Years Day for full‑time global employees. Equal Employment Opportunity BMS is an equal opportunity employer and encourages applicants from all backgrounds to apply. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, disability, or any other protected characteristic.
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  • Harvard, Illinois, United States

Languages

  • English
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