Specialist, QA Manufacturing Shop Floor Operations

About the role

Working at Bristol Myers Squibb is challenging, meaningful, and life-changing. Here, uniquely interesting work happens every day, in every department—from optimizing a production line to the latest breakthroughs in cell therapy. This is work that transforms 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, taking your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide employees with resources to pursue their goals, both at work and in their personal lives.

Responsibilities

• Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
• Interpret problems and prepare clear, concise, and accurate 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 within the 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.
• 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 for newer team members.
• Independently approve deviation records within the quality management system consistent with quality risk management principles and process knowledge.
• Review and interpret the technical conclusions of records/investigations 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 the team by acting as a champion for quality culture.
• Work within pharmaceutical cleanroom environments.

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 assigned work.
• Ability to work in a fast-paced team environment with changing priorities, limited information, and/or time constraints.
• Effective communication with cross-functional peers and various levels of management through technical writing and verbal skills.
• Active listening skills to understand unique working perspectives.
• Contributes to a positive team environment.
• Able to independently make decisions based on data and facts, and recognize when to escalate.
• Seeks opportunities for improvement to quality and operational problems.
• 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) 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.

Qualifications

• Bachelor’s degree in a 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.

Schedule

Day shift, 6:00 a.m. to 6:30 p.m. 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 a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate accounts for 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: 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 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.

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.