Quality Assurance Field 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.

Summary:
Primary responsibility is to maintain a presence and provide Quality oversight, coaching and support to manufacturing groups. Assists in the identification and generation of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.

Duties/Responsibilities:
• Serve as the primary QA contact for multiple manufacturing areas.
• 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.
• Assisting in deviation/nonconformance identification and resolution acting as team member to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution as required.
• Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.
• Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines.
• 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.
• Work with operations personnel to resolve issues in a GMP compliant manner.
• Perform quality tag outs of equipment as required.
• Support product change over activities.

Knowledge/Skill:
• Knowledge of biologics manufacturing is highly desirable.
• Knowledge of US and EU cGMP regulations and guidance.
• Experience with cGMP documentation review is highly desirable

Education/Experience/ Licenses/Certifications:
• 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
• Experience working directly with assurance of product quality is highly desired

*Shift: 12 hour rotating (6:00am - 6:00pm)

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.