Documentation Specialist Lead

5 days ago


Fremont, California, United States Fladger Assoc. Inc. Full time
Job Overview

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.
Requirements
  • 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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