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Jobs · Quality Assurance · Massachusetts

Specialist, QA Manufacturing Shop Floor Operations

Bristol Myers Squibb · Devens, MA · Yesterday
On-siteQuality Assurance$40.16–$48.67/hrFull-time

About the role

At Bristol Myers Squibb, uniquely interesting work happens every day, transforming the lives of patients and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. This role is part of the Quality Assurance Shop Floor team, responsible for 24x7 Quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Warehouse Operations. You will oversee and partner with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.

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).

Responsibilities

  • Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.
  • Interpret problems and effectively prepare communication for management and 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 for 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 the team by acting as a champion for quality culture.

Requirements

  • 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.
  • Prior experience with quality processes, including batch record review, material disposition, 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.

Skills

  • 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.
  • 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 unique 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.

Pay

Devens - MA - US: $40.16 - $48.67 per hour. The starting compensation range(s) for this role are listed for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s 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 for 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 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 who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

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