Quality Assurance Specialist

Tuesday-Saturday scheduleW-2 onlyJob **The Quality Assurance Specialist is responsible for implementing and overseeing GMP Quality Assurance processes. This includes managing Asset Management, Batch Records, Change Management, Deviation and CAPA, GMP Cleanroom Support, Lot Disposition, Quality Control (QC) Data, Quality Risk Management (QRM), and Raw Materials handling.The ideal candidate will have experience in GMP biopharmaceutical operations, clinical manufacturing, and quality management systems.Collaborate on continuous improvement of GMP processes and create/update SOPs.Represent QA on project-specific teams.Review and approve executed batch records, Change Management deliverables, Deviation and CAPA records.Provide quality support for cleanroom operations (e.g., changeover, line clearance, event triage).Review final product lot files for lot disposition.Participate in QRM activities (risk assessments).Review incoming raw materials and approve specifications.Write and revise SOPs as needed.Support routine QA operations as required.***BSc with 7+ years of experience in biology, biochemistry, chemical engineering, bioengineering, or related field, ORMSc with 4+ years of relevant experience.6+ years in GMP biopharmaceutical operations, with at least 4 years in a Quality role.Experience with clinical manufacturing and quality management systems (deviations, CAPAs, change management).

Created: 2025-02-22