Associate II, Shop Floor Quality Assurance Cell Therapy

Bristol Myers Squibb • Devens, MA

4d • $35 - $43 • 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. This position oversees and partners with operational areas to ensure compliance with Bristol Myers Squibb policies, standards, procedures, and Global cGMP.

The role is based in a modern manufacturing facility and follows a 6 a.m.–6 p.m. rotating Panama schedule, including holidays and weekends. Work may involve awareness of pressurized liquids and gases, steam, and hazardous chemicals. Personal protective equipment is required in some areas, including appropriate gowning for clean-room work.

Requirements

• Ability to understand, follow, and apply approved procedures.
• Basic computer skills, including knowledge of MS Office.
• Ability to understand problems and propose practical solutions.
• Effective written and verbal communication with cross-functional peers and direct management.
• Ability to work in a fast-paced team environment with changing priorities.
• Detail-oriented and task-focused, 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 or associate degree, with an equivalent combination of education and work experience potentially considered.
• 0–2 years of relevant cGMP experience.

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 clean-room 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 so that the floor and operations adhere to 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 execution of 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

• Wellbeing support.
• Retirement and financial protection benefits.
• Medical, dental, vision, life, and disability insurance offerings.
• For non-exempt employees: 160 hours of paid vacation annually for new hires, 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, 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.

What This Job Offers

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