Bristol Myers Squibb · 15 hours ago
NIGHT SHIFT: Senior Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA
Devens, MA
Full-time
Onsite
Mid, Senior Level
$90K/yr - $109K/yr
4+ years expBristol Myers Squibb is a leading biopharmaceutical company focused on transforming patients' lives through science. The Senior Specialist, Quality Assurance Shop Floor, Cell Therapy position involves ensuring GxP compliance and overseeing quality assurance in manufacturing and other operations, while collaborating with various departments to address quality issues and drive improvements.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience
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
Preferred
Bachelor's degree in STEM field preferred
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred
Benefits
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (213)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2025-12-30
BioWorld Financial Watch
2025-12-29
2025-12-25
Company data provided by crunchbase