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The Production Scientist I (Manufacturing) position will be responsible for the manufacture of laboratory reagents under GMP processes. The successful candidate will work within the Laboratory Ops team to provide high quality, regulated reagents for use in the Production Laboratory.
DUTIES AND RESPONSIBILITES
- Perform reagent manufacturing under Good Manufacturing Practice (GMP) protocols
- Manage SOPs and Master Batch Records (MBR) related to manufacture of reagent sub-components and final components
- Work directly with Supply Chain team to complete chain of custody of materials
- Work directly with Quality team to QC and release intermediate components for manufacture or use
- Keep detailed MBRs in compliance with necessary regulations (FDA, ISO, etc)
- Provide all MBRs or raw components records to Quality for storage and tracking
- Develop new methods for improving reagent assembly and work with Process Engineering team on automated methods
- Enter and track data in a laboratory information database (LIMS)
- Ensure laboratory compliance with regulatory agencies (CLIA, CAP, FDA)
- Manage inventory of raw materials and issue and track usage of finished materials
- Use ERP system (NetSuite) to develop manufacturing records linked to inventory control
- Provide training to manufacturing associates