Powder Production Clerk
Manufacturing | Santa Ana | CA
We are hiring a Powder Production Clerk. The Production Clerk is responsible for maintenance and flow of Production documents as well as monitoring for their accuracy and completeness for compliance with cGMP and GDP guidelines. Review of lot folders before submission to QA and ensuring that the lot folders are error free is a key function of this position. This individual is responsible for maintaining inventory of Production consumable items such as shoe covers, hairnets, lab coats, etc.
- Examine batch record documentation, materials, and monitor work processes, in order to assess completeness, accuracy, and conformance to cGMP and GDP standards and company policies
- Review documents such as production schedules and work orders to ensure adequate supplies and materials for the day’s production
- Maintain the record of production data in the Daily Production Record (DPR) file including units produced, in-process rejects, QC samples, etc.
- Requisition and maintain inventories of materials and processing supplies necessary to meet production demands
- Distribute production schedules and work orders to departments
- While reviewing the batch record, track types of errors by the technicians, create Prato charts, investigate root cause(s) and work closely with Production management and technicians to eliminate occurrence of those errors
- Optimize the batch record and production processes by proposing and submitting changes to the batch record and existing production SOPs
- Work with the technicians on the production floor to observe their activities and provide feedback on their documentation method
- High School Diploma or equivalent required
- Previous Manufacturing / Quality experience in bioscience, pharmaceutical or medical devices industry
- Working knowledge of GMP, GDP, ISO, FDA and OSHA regulatory requirements
- Proficient in using computers including MS Office
- Working experience with ERP system
- Working knowledge of batch records including GMP and GDP rules governing their accuracy and completeness
- Knowledge of metric system and its unit conversions
- Weighing of materials and supplies in Production areas
- Ability to learn processing methods that comply with current Good Manufacturing Practices (GMPs)
Principals only. No recruiters please.
FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.