Sr. Associate Plant QA 12 Hour Day Shift (6am - 6:30pm)
Core
Provide QA guidance and support to AOH production, perform Quality Batch Record Review for commercial batches, and ensure GMP compliance in device assembly and packaging areas.
Role type
Senior IC Quality Assurance Associate (Manufacturing)
Builds
Commercial batches of oncology, inflammation, general medicine, and rare disease medicines
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP operations, batch record review, SOP and work instruction management, deviation/CAPA/change control management, finished product inspection, regulatory inspection support, Lean transformation, safety compliance
Preferred skills
Life Sciences/Physical Sciences degree, GMP/GCP experience, data sciences and Quality engineering knowledge, raw material inspection, SAP/TrackWise/CDOCS proficiency
Responsibilities
Provide daily guidance to production staff on SOP compliance; Monitor GMP operations in assembly and packaging areas; Review and approve batch production records and controlled documents; Lead and coach operations personnel on quality matters; Perform finished product checks during production runs; Support internal and external regulatory inspections; Adhere to safety rules and EHSS goals
Seniority
Senior, hands-on IC