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. 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.

Position: Specialist, Quality Assurance Operations

Location: Devens, MA

****** Shift 9:00 am to 5:00pm ******

Key Responsibilities:

• Provides quality support to Devens Site through quality review and approval of deviations or change controls.  
• Supports technical transfer sub-teams and the review and approval of technology transfer documentation 
• Support automation forums. Provide review and approval of automation change management. May lead automation change management forums.
• Support review of the cell bank disposition program. May track and review deliverables.
• May support projects and incoming transfers for cell banking operations. 
• Review and approve Master Data for SAP and Syncade in support of tech transfer and projects. 
• Review and approve Maximo work orders, OOTs, extensions for PMs and Cals.
• May participate in projects with limited decision-making.
• May provide quality support for Manufacturing Science and Technology and Validation reports as well as periodic assessments. 
• Participates as requested in the response team for audits and inspections by world health authorities. 
• Represents QA in cross functional meetings.  

• Makes sound decisions by coordinating with higher level QA personnel and exercising judgment within generally defined practices and policies. 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.  

Qualifications & Experience:

• 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 systems including any of the following: SAP, LIMS, Infinity, LES, Vitalize, Maximo, Vault, and Syncade desirable.
• Experience working in a team-based environment with a diverse group of people.
• Excellent writing and oral communication skills are required.
• Bachelor´s degree in science, engineering, or other related discipline. 
• A minimum of 2 years' experience in biopharmaceutical quality or its equivalent with an additional 2-3 years of increasing responsibility preferred.
• Excellent written & oral communications skills.
• Capability to build alignment with peer level business partners.
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
• Demonstrate capability with ability to make and act on decisions while balancing speed, quality and risk. 
• Knowledge of biotech bulk and finished product manufacturing, analytical testing highly desirable.

Working Conditions

• Work in a cGMP manufacturing environment following techniques which require one to maintain a high attention to detail.
• Properly use Personal Protective Equipment (PPE), gowning for restricted areas, handling chemicals, and work in a general office environment.

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