Bristol-Myers Squibb Company

Lead, QA Manufacturing Operations

Devens, MA, United States
Aug 09, 2019
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required. Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality 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.


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

2. Perform walkthroughs of GMP areas documenting observations and areas o 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.

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

4. Authors and revises Quality specific SOPs and many provide Quality review and approval of manufacturing related SOPs.

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

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

7. May provide guidance to less experienced staff.

8. May support the Quality approval of Master Batch Records.

9. Supports the Quality review and closure manufacturing deviations.

10. May support release of incoming or manufactured products.

11. Other duties as assigned.

This role requires the selected individual to support a rotating 12 hour shift, which will include occasional weekend work.


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

2. A minimum of 4 years of relevant experience in a regulated environment with at least 2 years focused on product quality.

3. Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.

4. Knowledge of US and EC cGMP regulations and guidance.

5. Knowledge of electronic batch records 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 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 the resources to pursue their goals, both at work and in their personal lives.