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 (Manufacturing)
Builds
Compliant biopharmaceutical products for global patients
Domain
Biopharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Batch record review, area release activities, area audits, lot genealogy reporting, deviation assessment, floor observations, autoclave review, electronic logbook review, alarm review, GxP knowledge, problem-solving, attention to detail
Preferred skills
Experience with PAS-X, DeltaV, PCS/BMS, GQCLIMS, LAP MODA, SAP
Technologies
PAS-X, DeltaV, PCS/BMS, GQCLIMS, LAP MODA, SAP
Responsibilities
Perform batch review and release for paper and electronic records; conduct area audits and release activities; assess quality events and deviations; review electronic logs and alarms; support continuous improvement initiatives
Seniority
Mid-level, hands-on IC
