Bristol Myers Squibb · 1 hour ago
Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA
Devens, MA
Full-time
Onsite
Entry, Mid Level
$84K/yr - $101K/yr
2+ years expBristol Myers Squibb is a leading biopharmaceutical company focused on transforming patients' lives through science. The Specialist, QA Shop Floor Cell Therapy will oversee quality assurance on the shop floor, ensuring compliance with company policies and global cGMP standards while collaborating with operational areas.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations
Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy
Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members
Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures
Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques
Provide quality oversight for pre-planned return to service plans
Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners
Identify and propose improvements to programs, procedures, and practices
Review manufacturing batch records or QC testing records to ensure compliance with approved procedures
Review and provide feedback on documents such as forms, logbooks, and procedures
Maintain compliance with assigned learning plan. Provide integration support of newer team members
Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge
Review and interpret the technical conclusions of a record/investigation and provide constructive feedback
Participate in quality and shift meetings
Build and maintain relationships with core partner functions and seek collaborative solutions
Share data/knowledge within team by acting as a champion for quality-culture
Qualification
Required
Bachelor's degree in STEM field. High school diploma or associate's degree with equivalent combination of education and work experience is considered
2+ years of relevant cGMP experience with 1+ year of manufacturing site experience
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing
Must be action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking
Ability to understand, follow, and apply internal policies, procedures, and quality principles
Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management
Ability to assess an unfolding situation, diagnose the problem, and propose practical solutions
Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work
Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints
Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills
Active listening skills to understand diverse working perspectives
Contributes to a positive team environment
Able to independently make decisions based on data and facts, and recognizes when to escalate
Seeks opportunities for improvement to quality and operational problems
Ability to work within pharmaceutical cleanroom environments
Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management
Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms
Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc
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
Additional time off for employees may include unlimited paid sick time, 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 (247)
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