HOW YOU WOULD CONTRIBUTE: Prepare and distribute daily, weekly and monthly reports related to batch production, batch release and department performance (e.g., monthly metric reporting, review priority email, error tracking, review turnaround-times by document type, workflow volume by document type, etc.)• Propose, develop and work with IS teams to implement new data analysis and reporting tools• Review and release of Production Batch Records for Packaging• Assist other QA groups and QA management with ad-hoc data entry and data analysis requests (e.g., track and trend)• Review and approval/rejection of Master Batch Records (MBRs), Packaging Batch Records, Rework Procedures (RPAs), and Document Change Requests.• Ensure adherence with GMPs and SOPs.• Determine disposition of finished goods and release or reject as appropriate.• Is primarily responsible for the review, approval, and archival of Master Batch Records (MBRs); review and issuance of packaging/manufacturing records; issuance of quality incident reports; Finished Product disposition (release / reject); and review of various batch related documents (RPAs, AQLs, LIRs, COAs, TDAs, QIRs, NMRs, MRRs, etc.) in regards to finished product disposition.