Senior Specialist, QA Shop Floor M-F, Cell Therapy

About the Role

Working at Bristol Myers Squibb offers uniquely interesting work that is challenging, meaningful, and life-changing. The Quality Assurance Shop Floor team provides 24x7 Quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Warehouse Operations. This position works a Monday to Friday day shift and serves as a Shop Floor Representative, interacting with various teams to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.

The Senior Specialist, Shop Floor QA, monitors and tracks process performance, owns or approves GxP records, and represents Shop Floor QA at governance forums. This role supports deviation approval, alarm approval, and other Quality System Records, requiring effective communication, critical thinking, and a thirst for knowledge.

Responsibilities

• Provide Quality oversight to Manufacturing, QC, Warehouse, and Packout operations.
• Identify departures from approved procedures and respond to complex issues independently; escalate critical issues to management.
• Perform and document operational verification per approved procedures.
• Develop, review, and/or approve temporary and non-routine procedures for event response.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Coordinate and lead area walkthroughs to identify quality issues; negotiate remediations and drive alignment of implementation plans.
• Own actions for departmental programs and propose improvements.
• Participate in Gemba walks.
• Communicate and resolve discrepancies independently and escalate as required.
• Author, review, and approve procedural documents.
• Maintain compliance with assigned learning plan; provide guidance and training for QA personnel.
• May own training curriculum and content; present individual topics during audits as needed.
• Independently assess discrepancies for entry into the quality system and approve deviations as applicable.
• Serve as a quality subject matter expert for risk assessments, change controls, etc.
• Lead meetings and represent the function at cross-functional meetings.
• Share data and knowledge within and across teams; build and maintain strong relationships with partner functions.
• May prioritize and assign tasks for the team.
• Periodically observe operations on the floor and proactively identify risks and drive improvements.
• Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals.
• Function as a project manager, influencing others based on time and task commitments, and organize/run meetings.
• Obtain access to and develop expertise in various electronic systems utilized by Shop Floor Quality (e.g., BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity).
• Familiarity with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring, and Reporting.
• Act as a champion for quality culture and learning by sharing data and knowledge across teams.

Requirements

• Ability to research, understand, interpret, and apply internal SOPs, policies, and regulatory guidelines.
• Proficient computer skills with knowledge of digital tools such as MS Office and ability to learn new software applications.
• Ability to interpret data and results, understand complex problems with multiple variables, and articulate practical solutions.
• Excellent written and verbal communication skills; ability to present technical data effectively based on the target audience.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Detail-oriented and task-focused with the ability to meet deadlines and support work prioritization.
• Ability to negotiate and influence to craft mutually beneficial solutions.
• Ability to motivate and foster a positive team environment.
• Strong decision-making ability and creative thinking while maintaining compliance and quality.
• Pioneering mindset and ability to create innovative solutions.
• Demonstrated experience with quality management systems for handling records such as change control, product complaints, deviations, investigations, and CAPA management.
• Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.
• 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.
• 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Demonstrated experience with GxP electronic systems such as Quality Management Systems (QMS), Manufacturing Execution Systems (MES) for electronic batch records, Enterprise Resource Planning (ERP) like SAP, laboratory information management systems, or electronic logbooks/forms.

Working Conditions

• Able to gown for ISO 8 rooms (medical scrubs, safety shoes, safety glasses, gloves, etc.).

Pay

Devens, MA, US: $89,780 - $108,789 (starting compensation range for a full-time employee). Additional incentive cash and stock opportunities may be available based on eligibility. 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 for 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.

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 for the Global Shutdown.

Schedule

This position works a Monday to Friday day shift.