Batch Record Reviewer in Fremont, CA at Apex Life Sciences

Date Posted: 2/12/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Fremont, CA
  • Job Type:
    Other
  • Experience:
    At least 2 year(s)
  • Date Posted:
    2/12/2018
  • Job ID:
    821898

Job Description


Duties

  • Leads all paper and electronic batch record review that is related to manufacturing of drug substance in a multi-product facility.
  • Performs duties under limited supervision and according to standard operating and manufacturing procedures.
  • 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.


Skills:

  • Bachelors degree, preferably in the life sciences field required
  • 2+ years of professional experience in a GMP environment.
  • Will also consider an Associate's degree with 4+ years of professional experience in a GMP environment 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