Senior Specialist, QA Shop Floor, Cell Therapy in Devens, MA

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Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition backed by a best-in-the-industry team and long-term commitment we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself accelerate your career and give new hope to patients theres no better place than here at BMS with our Cell Therapy team.

The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations including but not limited to Manufacturing Quality Control laboratories and Warehouse Operations.

The Senior Specialist Quality Assurance Shop Floor Cell Therapy position will oversee and partner with operational areas to ensure GxP compliance with Bristol-Myers Squibb policies standards procedures and Global cGMP.

In the capacity of QA Shop Floor the Senior Specialist shall serve as one of the Quality Representatives interacting with Manufacturing Supply Chain Quality Control and other supporting functions.

The Senior Specialist QA Shop Floor is accountable to own quality decision making as it relates to unexpected events on the production floor deviation triage and determination. Participation in cross-functional triage meetings. They own; review or quality approve GxP records including but not limited to procedures batch records or deviations. Additionally the incumbent shall support deviation approval alarm approval and other Quality System Records as requested by management. Effective communication critical thinking and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed.

Shifts Available:

A1 & B1 - 6am - 6pm rotational schedule including holidays and weekends

Responsibilities:

• Provide Quality oversight to Manufacturing/QC/Warehouse/ Packout operations. Identify departures from approved procedures & respond to complex issues independently & escalate critical issues to management.
• May perform and document operational verification per approved procedures.
• Develops reviews and/ or approves temporary and non routine procedure for event response.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans.
• Own actions for departmental programs and propose improvements to programs.
• Communicate and resolve discrepancies independently and escalate as required.
• Author review and approve procedural documents.
• Maintain compliance with assigned learning plan. Provide guidance and training for QA personnel.
• May own training curriculum and content.
• Independently assess discrepancies for entry into quality system and approve records as applicable.
• Lead meetings and represent function at cross functional meetings.
• Share data/knowledge within and across team. Build & maintain strong relationships with partner functions.
• May prioritize and assign tasks for the team.
• Observe operations occurring on the floor and proactively identify risks and drive improvements.
• Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals.
• Able to influence others based on time and task commitments organize/run meetings.
• Obtain access to and develop as an SME for various electronic systems utilized by Quality Assurance Shop Floor (BMSDocs CELabs MES SAP ValG DeltaV Maximo Infinity etc.).
• Should be familiar with GMP-related systems including Quality Risk Management Document and Data Governance Monitoring and Reporting.

Knowledge and Skills:

• Ability to research understand interpret and apply internal SOPs policies and regulatory guidelines.
• Proficient computer skills with knowledge of digital tools such as MS Office etc. and ability to learn and work with new software applications.
• Ability to interpret data & results understand complex problems with multiple variables and articulate practical solutions.
• Excellent written and verbal skills and ability to present technical data effectively based on target audience.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Detail oriented and task focused with ability to meet deadlines and support work prioritization.
• Ability to negotiate and influence to craft mutually beneficial solutions.
• Ability to motivate and foster a positive team environment.
• Exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
• Demonstrated experience with quality management systems for handling of records such as change control product complaints deviations investigations and CAPA management.
• Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate Smartsheet Tableau etc.
• Demonstrated experience with quality management systems
• Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.

Basic Requirements:

• Bachelors degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 4 years of relevant cGMP experience preferably with 1 year of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

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If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical pharmacy dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability life insurance supplemental health insurance business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours flexibility. Parental caregiver bereavement and military leave. Family care services such as adoption and surrogacy reimbursement fertility/infertility benefits support for traveling mothers and child elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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