Batch Record Reviewer II

Responsibilities:

• Excellent employment opportunity for a Batch Record Reviewer II 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.
• 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: MANUFACTURING PROCESSES, BATCH RECORD, CLEAN ROOM, GMP, EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
• Additional Skills: ASSEMBLY, LIFE SCIENCE, QA, BATCH RECORD REVIEW, DOCUMENTATION, PROCESS IMPROVEMENT, MICROSOFT OFFICE, BATCH RECORDS, INVENTORY