Verbal and written communication skills
Knowledge of Good Documentation Practices(GDP); must be able to provide coaching on GDP
Must be able to work with minimal supervision
Must be able to promote teamwork- Must be able to interface with other teammates.
Experience: High School diploma; associate degree/bachelor degree a plus. Minimum 4 years’ experience in FDA/ISO regulated industry with at least 2 years’ experience in batch records review. Extensive knowledge of Good Documentation Practices (GDP). Must be organized and detail oriented.
Position Summary: Review/release of incoming raw materials, manufacturing batch records/traveler according to standard operating procedures.
Ensure compliance of batch records/traveler, deviations and supporting documents with internal procedures and good documentation practices.
Interface with production teammates to ensure expedited closure of issues/discrepancies detected during batch records review