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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 .

At **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, there's 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:

B2 - 6pm - 6am, rotating schedule including holidays and weekends, onsite

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 SOP's, 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:

+ Bachelor's 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 doesn't 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.

Compensation Overview:

Devens - MA - US: $89,780 - $108,789

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 employee's 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 https://careers.bms.com/life-at-bms/.

Benefit 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 Year's 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.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

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.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

**Company:** Bristol-Myers Squibb

**Req Number:** R1595314

**Updated:** 2025-10-03 05:00:33.605 UTC

**Location:** Devens-MA

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.