Bristol Myers Squibb
biopharmaceuticals
Specialist,QAOperationsShopfloor
“Specialist, QA Operations Shopfloor at Bristol Myers Squibb. Skills: QA Operations, cGMP Compliance, Process Management. Provide Quality on-the-floor oversight. Identify departures from approved procedures”
Industry & Context.
Ability to understand problems and propose practical solutions
What They're Looking For.
Must Have
0-2 years of relevant cGMP experience
Nice to Have
Bachelor's degree in engineering, a life or physical science related field (including biology, biochemistry, chemistry), Experience in FDAA regulations in biopharmaceuticals or cell therapy manufacturing, Experience with quality management systems, Experience with electronic system and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP)
What You'll Do.
Provide Quality on-the-floor oversight
Identify departures from approved procedures
Respond to issues independently
Assess discrepancies for entry into quality system
Perform and document operational verification
Observe manufacturing operations
Identify departures from clean room behaviors
Identify departures from aseptic techniques
Provide quality oversight to maintenance operations
Support pre-approved return to service plans
Perform area walkthroughs
Identify quality issues
Support implementation
Ensure floor and operations adherence
Review manufacturing or testing records
Ensure compliance with approved procedures
Communicate and resolve discrepancies
Author and review department owned documents
Maintain compliance with assigned learning plan
Support integration of newer team members
Support internal and external inspections
How You'll Work.
Team & Collaboration
Partner with Manufacturing, Quality Control laboratories, and Warehouse Operations; Escalate more complex issues to senior members; Communicate in professional manner; Share data/ knowledge within team; Build relationships with specialized function
Communication Scope
Ability to communicate effectively with cross functional peers and various levels of cross functional management through written and verbal skills
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