Job Description

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 BMSs 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.
* Performs 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 and may provide Quality review and approval of manufacturing related SOPs.
* Assists Operations by providing quality oversight and guidance for atypical events.
* May provide guidance to less experienced staff.
* May support the Quality approval of Master Batch Records.

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.
* A minimum of 4 years of relevant experience in a regulated environment with 2 years focused on product quality preferred.
* 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. This is a third shift position working Monday to Thursday 9:30PM to 7:30AM.

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.