Quality Assurance Specialist II
Core
Provide Quality Assurance oversight for manufacturing and operational activities in a biopharmaceutical environment, ensuring compliance with regulations and company standards.
Role type
Quality Assurance Specialist II
Builds
Batch records, area releases, lot genealogy reports, and compliance documentation for life-changing medicines.
Domain
Biopharmaceutical manufacturing
Required skills
Batch record review, area release activities, area audits, lot genealogy reporting, deviation assessment, floor observations, autoclave review, electronic logbook review, PCS/BMS alarm review, GxP knowledge, Lean initiatives
Preferred skills
Experience with PAS-X, DeltaV, PCS/BMS, GQCLIMS, LAP MODA, SAP systems
Technologies
PAS-X, DeltaV, PCS/BMS, GQCLIMS, LAP MODA, SAP
Responsibilities
Perform batch review and release for paper and electronic records; conduct area audits quarterly; prepare and review lot genealogy reports; assess quality events for deviation initiation; review autoclave run cycles; review electronic manufacturing records and alarms; participate in continuous improvement projects.
Seniority
Mid-level, hands-on IC
