Field Quality Assurance Specialist, Manufacturing Operations

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.

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

3. Perform walkthroughs of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas. Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.

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

5. Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs.

6. Monitors and trends batch record errors, batch record review cycle time to support disposition, and walkthrough observations to provide Quality Assurance management with quality indicator data.

7. Assist Operations by providing quality oversight and guidance for atypical events.

8. Provide guidance to less experienced staff.

9. Support the Quality approval of Master Batch Records.

8. Supports the Quality review and closure manufacturing deviations.

10. May support release of incoming or manufactured products.

11. Other duties as assigned.

Knowledge, Skills, and Qualifications:

• 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 product quality.
• 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 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. Must be able to work directly in clean room environment for up to 50% of shift.

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.