Specialist, Quality Assurance Shop Floor
Bristol Myers Squibb
10 hours ago
On-site
Devens, MA
Operations
Position Summary
- Quality Assurance Shop Floor team provides 24x7 Quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Warehouse Operations.
- Oversee and partner with operational areas to ensure compliance with BMS policies, standards, procedures, and Global cGMP.
Shift
- NIGHT shift: Panama schedule (12-hour shift patterns; 2-2-3 work cycle including weekends and holidays), 6 pm to 6 am.
Duties/Responsibilities
- Provide routine on-the-floor Quality oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain.
- Interpret problems and communicate clearly, accurately, and concisely to management and teams.
- Identify departures from approved procedures; respond independently and escalate complex issues to senior members.
- Perform and document operational verification within MES per approved procedures.
- Observe manufacturing operations; identify departures from procedures, cleanroom behaviors, and aseptic techniques.
- Provide quality oversight for pre-planned return to service plans.
- Conduct area walkthroughs to identify quality issues, propose remediations, and support implementation.
- Identify and propose improvements to programs, procedures, and practices.
- Review manufacturing batch records and QC testing records for compliance.
- Review and provide feedback on documents (forms, logbooks, procedures).
- Maintain compliance with assigned learning plan; provide integration support for newer team members.
- Independently approve deviation records in the quality management system using quality risk management principles.
- Review and interpret technical conclusions from records/investigations and provide constructive feedback.
- Participate in quality and shift meetings.
- Build and maintain relationships with core partner functions; seek collaborative solutions.
- Share data/knowledge and champion quality-culture.
Qualifications
Required / Skills & Abilities
- Action-oriented; proficient in decision-making, relationship building, problem-solving, and analytical thinking.
- Understand, follow, and apply internal policies, procedures, and quality principles.
- Assess unfolding situations, diagnose problems, and propose practical solutions.
- Detail-oriented; meet deadlines; prioritize work.
- Effective in fast-paced environments with changing priorities and limited information/time.
- Communicate effectively across functions and management via technical writing and verbal skills.
- Active listening; contributes to a positive team environment.
- Independently make data-based decisions; recognize when to escalate.
- Seek opportunities to improve quality and operational problems.
- Ability to work in pharmaceutical cleanroom environments.
- Experience with quality management systems handling records (change control, product complaints, deviations, investigations, CAPA).
- Experience with GxP electronic systems: MES (electronic batch records), ERP (e.g., SAP), LIMS, electronic logbooks/forms.
- Proficient with digital tools (e.g., Microsoft Power Automate, Smartsheet, Tableau).
Education/Experience
- Bachelor’s degree in a STEM field (high school diploma or associate’s degree with equivalent education/work experience considered).
- 2+ years of relevant cGMP experience, including 1+ year of manufacturing site experience.
- Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
Compensation & Benefits (as stated)
- Devens, MA: $40.16–$48.67 per hour.
- Health coverage (medical, pharmacy, dental, vision); wellbeing support programs (Well-Being Account, Living Life Better, EAP); financial protection (401(k), disability, life insurance, accident insurance, supplemental health, business travel protection, personal liability protection, identity theft benefit, legal support, survivor support).
- Paid Time Off: includes flexible time off/paid national holidays (details vary by employee type/location).
Application instructions
- If the role interests you but your resume doesn’t fully match, apply anyway.
- Quality Assurance Shop Floor team provides 24x7 Quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Warehouse Operations.
- Oversee and partner with operational areas to ensure compliance with BMS policies, standards, procedures, and Global cGMP.
Shift
- NIGHT shift: Panama schedule (12-hour shift patterns; 2-2-3 work cycle including weekends and holidays), 6 pm to 6 am.
Duties/Responsibilities
- Provide routine on-the-floor Quality oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain.
- Interpret problems and communicate clearly, accurately, and concisely to management and teams.
- Identify departures from approved procedures; respond independently and escalate complex issues to senior members.
- Perform and document operational verification within MES per approved procedures.
- Observe manufacturing operations; identify departures from procedures, cleanroom behaviors, and aseptic techniques.
- Provide quality oversight for pre-planned return to service plans.
- Conduct area walkthroughs to identify quality issues, propose remediations, and support implementation.
- Identify and propose improvements to programs, procedures, and practices.
- Review manufacturing batch records and QC testing records for compliance.
- Review and provide feedback on documents (forms, logbooks, procedures).
- Maintain compliance with assigned learning plan; provide integration support for newer team members.
- Independently approve deviation records in the quality management system using quality risk management principles.
- Review and interpret technical conclusions from records/investigations and provide constructive feedback.
- Participate in quality and shift meetings.
- Build and maintain relationships with core partner functions; seek collaborative solutions.
- Share data/knowledge and champion quality-culture.
Qualifications
Required / Skills & Abilities
- Action-oriented; proficient in decision-making, relationship building, problem-solving, and analytical thinking.
- Understand, follow, and apply internal policies, procedures, and quality principles.
- Assess unfolding situations, diagnose problems, and propose practical solutions.
- Detail-oriented; meet deadlines; prioritize work.
- Effective in fast-paced environments with changing priorities and limited information/time.
- Communicate effectively across functions and management via technical writing and verbal skills.
- Active listening; contributes to a positive team environment.
- Independently make data-based decisions; recognize when to escalate.
- Seek opportunities to improve quality and operational problems.
- Ability to work in pharmaceutical cleanroom environments.
- Experience with quality management systems handling records (change control, product complaints, deviations, investigations, CAPA).
- Experience with GxP electronic systems: MES (electronic batch records), ERP (e.g., SAP), LIMS, electronic logbooks/forms.
- Proficient with digital tools (e.g., Microsoft Power Automate, Smartsheet, Tableau).
Education/Experience
- Bachelor’s degree in a STEM field (high school diploma or associate’s degree with equivalent education/work experience considered).
- 2+ years of relevant cGMP experience, including 1+ year of manufacturing site experience.
- Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
Compensation & Benefits (as stated)
- Devens, MA: $40.16–$48.67 per hour.
- Health coverage (medical, pharmacy, dental, vision); wellbeing support programs (Well-Being Account, Living Life Better, EAP); financial protection (401(k), disability, life insurance, accident insurance, supplemental health, business travel protection, personal liability protection, identity theft benefit, legal support, survivor support).
- Paid Time Off: includes flexible time off/paid national holidays (details vary by employee type/location).
Application instructions
- If the role interests you but your resume doesn’t fully match, apply anyway.