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Field Quality Assurance Operations, Single Use Facility

Provide Quality assistance and oversight during start up of clinical manufacturing facility and manufacturing of clinical/commercial drug substance. Performs review and approval of records for the manufacture of in-process materials, drug substance and other GMP processes as required. Assists in the identification, generation and review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.
Responsibilities:
1. Assures all electronic and paper documentation, which requires QA review is in compliance with corporate as well as site procedures, regulations, and other industry guidelines.
2. Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs.
3. Performs walkthroughs of the manufacturing facility and applicable support areas documenting observations and points of concern.
4. Supports return to service walkthroughs and other walkthroughs per procedures as needed.
5. Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing and support area related SOPs.
6. Monitors and trends batch record error and right-first-time batch record review cycle times.
7. Supports disposition and provides Quality Assurance management with quality indicator data. Supports the Quality review and closure of low risk investigations.
8. Participates in the creation of a team based environment, promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals.
9. Demonstrates appropriate examples of compliance behaviors and attitudes. Supports on the floor activities in collaboration with Manufacturing and additional support groups as needed.
10. Other duties as assigned.
Education/Experience/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.
- A minimum of 4 years of relevant experience in a regulated environment with at least 2 years focused on quality, validation or manufacturing operations.
- Knowledge of biotech bulk manufacturing, disposable technologies and analytical testing is highly desirable.
- Knowledge of US and EU cGMP regulations and guidance for clinical and commercial phase products is preferred.
- Knowledge of electronic and paper batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking and maintenance is desirable.
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, disability or protected veteran status.

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