The Product Quality Batch Release (PQBR) Compliance Specialist III will perform the necessary activities to ensure compliance requirements and manufacturing/release schedules are met.
Position Responsibilities:
Quality Review of Batch Records
Quality Review of Lot Release Protocols (LRP)
Disposition of Batches
Compliance and Performance
Skills:Working knowledge of cGMPs and regulatory requirements
Knowledge of vaccines/biologics products and associated technologies
The ability to work on cross functional project teams
Meet/Exceed project timelines/deliverables
Experience with Quality Systems including: SAP, Quality eDoc, LabWare, TrackWise and MS Office
Strength in several LEAD Competencies - Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions
Education:Basic Qualifications:
Bachelor's degree in Science or Life Science's
3-4 years in a cGMP/ controlledQuality environment in the pharmaceutical industry
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