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Documentation Specialist I

companyFladger Assoc. Inc.
locationFremont, CA, USA
PublishedPublished: 6/14/2022
Full Time

Job Description

Fremont, CAContract Duration: 5-24 monthsRate: Negotiable

Responsibilities:

  • Excellent employment opportunity for a Documentation Specialist I in the Fremont, CA area.
  • This position leads all paper/electronic batch record review that is related to manufacturing of drug substance in a multi-product facility.
  • The position performs duties under limited supervision and according to standard operating and manufacturing procedures.
  • It contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines are met.
  • Independently executes (paper/electronic) batch record review
  • Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.

Experience:

  • Requires 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, will consider an Associate's Degree plus 4 years of professional experience in a GMP environment or clean room assembly environment.
  • Demonstrated proficiency in MS Office programs and associated computer programs.
  • Technical knowledge of manufacturing systems, methods and procedures.
  • Must have 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
  • Additional Skills: ASSEMBLY, LIFE SCIENCE, MS OFFICE, BATCH RECORD, BATCH RECORDS, INVENTORY, MICROSOFT OFFICE, PROCESS IMPROVEMENT, QA, EXCELLENT WRITTEN
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