Specialist, Quality Assurance Shop Floor, Cell Therapy

About the Role

Working at Bristol Myers Squibb offers challenging, meaningful, and life-changing opportunities. The Quality Assurance Shop Floor team provides 24x7 Quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Supply Chain/Warehouse Operations. This role ensures compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.

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

Responsibilities

• Provide Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
• Interpret problems and prepare supporting communication for management and the team 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 per approved procedures.
• Observe manufacturing operations and identify departures from procedures, cleanroom behaviors, and aseptic technique.
• Perform area walkthroughs to identify quality issues and support remediation to ensure adherence to cGMP and approved procedures.
• Review manufacturing batch records, logbooks, and/or QC testing records to ensure compliance with approved procedures; communicate and resolve discrepancies.
• Independently approve deviation records within the quality management system consistent with quality risk management principles.
• 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; communicate professionally and share knowledge within the team.
• Build and maintain relationships with core partner functions and seek collaborative solutions.
• Obtain access to, and 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 assigned work.
• Ability to work in a fast-paced team environment with changing priorities and limited information/time constraints.
• Effective communication skills for cross-functional peers and various levels of management through technical writing and verbal skills.
• Ability to independently make decisions based on data and facts, and recognize when to escalate.
• Active listening skills to understand diverse working perspectives.
• Contributes to a positive team environment and seeks opportunities for improvement to quality and operational problems.
• 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 such as Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) software (e.g., SAP), laboratory information management systems (LIMS), and 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 an 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.

Pay

Starting compensation range: $40.16 - $48.67 per hour for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate considers required skills, job location, work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

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:
  • Paid Time Off:
    • 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 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 (based on eligibility) 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.

All global employees (full and part-time) actively employed and paid directly by BMS at the end of the calendar year are eligible for the Global Shutdown.