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Bristol Myers Squibb Field Quality, QA Operations Analyst in Devens, Massachusetts

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Primary Responsibility:

  • This role will primarily support the Devens Single Use drug substance manufacturing facility. At the Single Use Facility (SUF), we produce clinical and commercial drug substance and cell banks to support BMS’s product pipeline using innovative disposable technology. The Field Quality Operations Analyst will provide support for daily manufacturing operations in the Single Use Facility.

Job Responsibilities:

  • Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs.

  • Perform walkthroughs of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas.

  • Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines.

  • Authors and revises Quality specific SOPs.

  • Supports Operations by providing quality feedback and collaboration for atypical events.

  • May support the Quality review of manufacturing deviations.

Knowledge and Skills:

  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.

  • 2 years relevant experience in a regulated environment is preferred.

  • Knowledge of biotech bulk and finished product manufacturing is desirable.

  • Familiarity with US and EU cGMP regulations and guidance.

  • Working knowledge of common computer systems such as MS-Word and Excel is required.

  • Knowledge of electronic batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking and maintenance is desirable.

Working Conditions:

  • Work is largely performed in a modern manufacturing facility where one must be aware of the presence of workplace standards including pressurized liquids gases, steam and hazardous chemicals. Use of Personal Protective Equipment (PPE) will be required in some portions of the facility, including appropriate gowning for working in a clean room environment. Working hours are first shift Monday through Friday.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol Myers Squibb

Req Number: R1532948-en-us

Updated: 2021-01-24 03:21:29.939 UTC

Location: Devens,Massachusetts

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.