Specialist, Quality Assurance Shop Floor, Cell Therapy

About the Role

Working at Bristol Myers Squibb is challenging, meaningful, and life-changing. Here, uniquely interesting work happens every day, transforming the lives of patients and the careers of those who do it. You’ll grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams in a supportive culture that values passion, innovation, urgency, accountability, inclusion, and integrity.

Bristol Myers Squibb offers a wide variety of competitive benefits, services, and programs to support employees in pursuing their goals, both at work and in their personal lives.

Responsibilities

• Provide 24x7 Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
• Interpret problems and prepare clear, accurate, and productive communication for management and the team.
• Identify departures from approved procedures and respond to issues independently; escalate complex issues to senior members.
• Perform and document operational verification per approved procedures.
• Observe manufacturing operations to identify departures from procedures, cleanroom behaviors, and aseptic technique.
• Conduct area walkthroughs to identify quality issues and support remediation, ensuring adherence to cGMP and approved procedures.
• Review manufacturing batch records, logbooks, and/or QC testing records for compliance with approved procedures; resolve and escalate discrepancies.
• Independently approve deviation records within the quality management system, consistent with quality risk management principles and process knowledge.
• Provide quality oversight for pre-planned return to service plans.
• Support internal and external inspections as required.
• Identify improvement opportunities and support execution of site/team continuous improvement goals and projects.
• Maintain compliance with assigned learning plan and provide integration support for newer team members.
• Participate in quality and shift meetings, cross-department and cross-functional meetings; act as a champion for quality culture.
• Build and maintain relationships with core partner functions and seek collaborative solutions.
• Develop expertise in various electronic systems utilized by Quality Assurance Shop Floor (MES/Syncade, SAP, Infinity and BMSDocs (Veeva), CELabs, ValGenesis, DeltaV, Maximo, etc.).

Requirements

• Action-oriented with proficiency in decision-making, relationship-building, 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.
• Detail-oriented and task-focused with the ability to meet deadlines and prioritize work in a fast-paced team environment with changing priorities.
• Strong communication skills (technical writing and verbal) for cross-functional collaboration and management interactions.
• Ability to independently make data-driven decisions and recognize when to escalate.
• Active listening skills to understand unique working perspectives.
• Contributes to a positive team environment and seeks opportunities for improvement.
• Ability to work within pharmaceutical cleanroom environments.
• Experience with quality management systems for handling records such as change control, product complaints, deviations, investigations, and CAPA management.
• Experience with GxP electronic systems (e.g., Manufacturing Execution Systems (MES), ERP software like SAP, LIMS, electronic logbooks/forms).
• Basic computer skills with proficiency in MS Office.
• Self-motivated with a willingness to learn.

Qualifications

• Bachelor’s degree in a STEM field preferred. High School diploma/Associate’s degree with equivalent combination of education and work experience may be considered.
• 2+ years of relevant cGMP experience with 1+ year of manufacturing site experience.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

Schedule

Night shift: 6 PM – 6 AM, Panama schedule (12-hour shift patterns with a 2-2-3 work cycle, including weekends and holidays).

Pay

Devens, MA (US): $40.16 - $48.67 per hour for full-time employees. Additional incentive cash and stock opportunities may be available based on eligibility. The starting pay rate reflects required skills, job location, work schedule, and relevant experience. Final compensation will be determined based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: 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.
• Work-life Benefits:
  • 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).
  • Phoenix, AZ, Puerto Rico, and Rayzebio Employees: 160 hours annual paid vacation for new hires (with manager approval), 11 national holidays, and 3 optional holidays.
  • Additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence (medical, personal, parental, caregiver, bereavement, military), and an annual Global Shutdown between Christmas and New Year’s Day.

Eligibility for benefits may vary based on job and location. All global full- and part-time employees actively employed at and paid directly by BMS at the end of the calendar year are eligible for the Global Shutdown.