Senior Specialist, Field Quality QA Operations ( Second Shift)

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

As our Sr Specialist, Field Quality QA Operations, you will 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.

Shift Available:

• Monday - Friday, Onsite Afternoon Shift (2 p.m. - 10:30 p.m.)

Responsibilities:

• Quality floor support of complex manufacturing activities

• Performs 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. 

• Perform training on routine facility Quality tasks for new team members.

• 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.

Knowledge & Skill:

• 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 or 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.

• Field Quality may have business needs to interact with any employee at any level of the Devens Facility with daily interactions with other Quality staff, Supply Chain, Digital Plant, Site Engineering and Manufacturing staff, as they conduct record reviews and respond to events occurring during day to day operations.

• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.  Coordinates with higher level leads and/or supervisor on decisions and applies appropriate notification to management as appropriate.

• Receives assignments which require the application of a defined process to complete the assignment.  As such specific assignments are allocated based upon the recipient’s demonstrated capabilities with the degree of supervisory attention determined accordingly.

Basic Requirements:

• Bachelor degree in science, engineering, biochemistry or related discipline, or its equivalent is preferred.

• 4 years of Quality Assurance experience within the pharmaceutical or medical device industry.

• Batch record review experience.

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. 

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