Documentation Specialist Lead
5 days ago
Fladger Assoc. Inc. is seeking a highly skilled Documentation Specialist Lead to join our team in Fremont, CA.
Salary: Negotiable (estimated $80,000 - $110,000 per year based on industry standards and location)
Job Responsibilities- The successful candidate will lead all paper/electronic batch record reviews related to the manufacturing of drug substance in a multi-product facility.
- Responsibilities include performing duties under limited supervision and according to standard operating and manufacturing procedures.
- This role contributes to process improvement of batch records and turnaround times to ensure timely completion and QA batch disposition deadlines are met.
- The Documentation Specialist Lead will independently execute (paper/electronic) batch record reviews.
- Collaboration with Manufacturing teams is essential to resolve batch record discrepancies or errors related to Good Documentation Practices or Manufacturing Execution System (MES) inventory.
- A Bachelor's Degree, preferably in the Life Science Field, plus a minimum of 2 years of professional experience in a GMP environment.
- In lieu of a Bachelor's Degree, an Associate's Degree plus 4 years of professional experience in a GMP environment or clean room assembly environment may be considered.
- Demonstrated proficiency in MS Office programs and associated computer programs.
- Technical knowledge of manufacturing systems, methods, and procedures.
- Excellent written and verbal communication skills.
- Awareness and understanding of manufacturing processes.
- Required skills: BATCH RECORD REVIEW, DOCUMENTATION, MANUFACTURING PROCESSES, GMP, EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS.
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