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Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.Challenging.
Meaningful.
Life-changing.
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But working at Bristol Myers Squibb is anything but usual.
Here, uniquely interesting work happens every day, in every department.
From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
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Position: Associate II, Shop Floor Quality Assurance Cell TherapyLocation: Devens, MA facility 12 Hrs.
Day Shift position 6:00AM to 6:00PM, Rotating Panama shift schedule.Key ResponsibilitiesProvide Quality on-the-floor oversight to Manufacturing/ QC/ Warehouse/ Supply Chain operations.
Identify departures from approved procedures & responding to minor issues or escalating to senior members.Perform and document operational verification per approved procedures.Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.Provide quality oversight to maintenance operations and support of pre-approved return to service plansPerform area walkthroughs to identify quality issues and support remediation to ensure the floor and operations are in adherence with cGMP and approved procedures.Review manufacturing or testing records to ensure compliance with approved procedures.
Communicate and resolve discrepancies and escalate as required.Maintain compliance with assigned learning plan.Support internal and external inspections as required.Contribute to the assessment of discrepancies and initiation of quality events.Participate in cross-department and cross-functional meetings, communicate in professional manner and share data/ knowledge within team.
Build relationships within direct team and partner functions.Additional Qualifications/ResponsibilitiesQualifications & ExperienceBachelor's degree in STEM field preferred.High school diploma/ associate degree with equivalent combination of education and work experience may be considered.0-2 years of relevant cGMP experience.
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.Ability to understand, follow, and apply approved procedures.Possess basic computer skills with knowledge of MS Office.Ability to understand problems and propose practical solutions.Ability to communicate effectively with cross functional peers and direct management through written and verbal skills.Ability to work in a fast-paced team environment with changing priorities.Detail oriented and task focused, with ability to meet deadlines and prioritize assigned work.Ability to recognize the need for escalation of issues.Self-motivated and willingness to learn.