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
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
