Specialist, Quality Assurance Shop Floor, Cell Therapy (Day Shift 6am-6pm Rotating Shift Schedule)

About the Role

Working at Bristol Myers Squibb offers uniquely interesting, life-changing work across departments, including optimizing production lines and breakthroughs in cell therapy. This position is a Specialist, Quality Assurance Shop Floor role on a rotating 2-3-2 Panama schedule (6am to 6pm), providing 24x7 Quality collaboration and oversight of site operations such as Manufacturing, Quality Control laboratories, and Warehouse Operations. The role ensures GxP compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP, serving as a Quality Representative interacting with cross-functional teams.

Responsibilities

• Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
• Interpret problems and communicate effectively with management and teams with clarity, brevity, and accuracy.
• Identify departures from approved procedures and respond to issues independently, escalating complex issues as needed.
• Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures.
• Observe manufacturing operations to identify departures from procedures, cleanroom behaviors, and aseptic techniques.
• Provide quality oversight for pre-planned return to service plans and perform area walkthroughs to identify quality issues.
• 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 and support integration of newer team members.
• Approve deviation records within the quality management system consistent with quality risk management principles.
• Review and interpret technical conclusions of records/investigations and provide constructive feedback.
• Participate in quality and shift meetings, building relationships with core partner functions.
• Share data/knowledge within the team to champion quality culture.
• Develop expertise in various electronic systems utilized by Quality Assurance Shop Floor (e.g., BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity).

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.
• Ability to assess unfolding situations, diagnose problems, and propose practical solutions.
• Detail-oriented and task-focused with the ability to meet deadlines and prioritize work in a fast-paced environment.
• Effective communication and active listening skills to engage with cross-functional peers and management.
• Ability to work in pharmaceutical cleanroom environments.
• Experience with quality management systems for handling records such as change control, deviations, investigations, and CAPA management.
• Experience with GxP electronic systems such as Manufacturing Execution Systems (MES), ERP (e.g., SAP), laboratory information management systems, or electronic logbooks/forms.
• Proficiency with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.

Qualifications

• Bachelor's degree in a STEM field. High school diploma or associate’s degree with equivalent combination of education and work experience is also 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.

Pay

Starting compensation range for this full-time role in Devens, MA is $40.16 - $48.67 per hour. Additional incentive cash and stock opportunities may be available based on eligibility. Final compensation will be determined based on demonstrated experience.

Schedule

This position works a rotating 2-3-2 Panama schedule (6am to 6pm), Day shift.

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.
• Work-life Benefits:
  • US Exempt Employees: Flexible time off (unlimited, with manager approval) and 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio).
  • 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 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 Year's Day.

Eligibility for specific benefits may vary based on job and location.