Associate II, Shop Floor Quality Assurance Cell Therapy

Bristol Myers Squibb • Devens, MA

4d • Onsite

About The Position

The Quality Assurance Shop Floor team provides 24x7 quality collaboration and oversight of site operations, including Manufacturing, Quality Control laboratories, and Supply Chain Operations. The Associate II oversees and partners with operational areas to ensure compliance with Bristol Myers Squibb policies, standards, procedures, and global cGMP requirements. The position works on a rotating 6 a.m.–6 p.m. Panama schedule, including holidays and weekends, in a modern manufacturing facility.

Requirements

• 0–2 years of relevant cGMP experience.
• Ability to understand, follow, and apply approved procedures.
• Basic computer skills, including knowledge of Microsoft Office.
• Ability to understand problems and propose practical solutions.
• Effective written and verbal communication skills with cross-functional peers and direct management.
• Ability to work in a fast-paced team environment with changing priorities.
• Attention to detail and task focus, with the ability to meet deadlines and prioritize assigned work.
• Ability to recognize when issues need to be escalated.
• Self-motivation and willingness to learn.
• High school diploma, associate degree, or equivalent combination of education and work experience may be considered.

Nice To Haves

• Bachelor's degree in a STEM field.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.

Responsibilities

• Provide on-the-floor quality oversight to Manufacturing, Quality Control, and Supply Chain Operations; respond to minor issues or escalate them to senior team members.
• Perform and document operational verification according to approved procedures.
• Observe manufacturing operations and identify departures from cleanroom behaviors and aseptic techniques.
• Provide quality oversight to maintenance operations and support pre-approved return-to-service plans.
• Conduct area walkthroughs to identify quality issues and support remediation to ensure the floor and operations comply with cGMP and approved procedures.
• Review manufacturing or testing records for compliance with approved procedures; communicate and resolve discrepancies and escalate as required.
• Identify improvement opportunities and support site and team continuous-improvement goals and projects.
• Maintain compliance with the assigned learning plan.
• Support internal and external inspections as required.
• Contribute to discrepancy assessments and initiation of quality events.
• Participate in cross-department and cross-functional meetings, communicate professionally, and share data and knowledge within the team.
• Build relationships within the direct team and partner functions.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
• Non-exempt employees receive 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• May be eligible for discretionary cash incentives and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED