Sr. Associate Plant QA 12 Hour Night Shift (6pm- 6am)
Core
Provide QA guidance and support to production, perform batch record reviews, and monitor GMP operations in device assembly and packaging areas.
Role type
Senior Associate Plant QA (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 compliance, batch record review, SOP and work instruction adherence, deviation/CAPA/change control management, finished product inspection, document control, regulatory inspection support, Lean transformation, safety protocols
Preferred skills
Life Sciences/Physical Sciences/Applied Engineering degree, GMP/GCP operations knowledge, data sciences and Quality engineering affinity, raw material inspection experience, SAP/TrackWise/CDOCS proficiency
Responsibilities
Provide daily guidance to production staff on SOP compliance; Monitor GMP operations in assembly and packaging areas; Act as first point of contact for quality queries during packaging/labeling; Mentor operations and support personnel on quality matters; Review and approve batch production records and GMP documentation; Perform finished product checks during commercial production runs; Compile and review batch records for batch disposition; Own and approve controlled documents (SOPs, Work Instructions, Forms); Review and approve Deviation, CAPA, and Change Control records; Participate in internal/external regulatory inspections; Support Lean Transformation and Operational Excellence initiatives; Adhere to safety rules and maintain a safe work environment
Seniority
Senior, hands-on IC