• Responsible for receiving and processing finished packaging batch records, raw materials, bulk materials.• Analyze finished product Batch records to ensure compliance and procedural requirements met before product release to market.• Perform queries in QMS (TrackWise Harmony) to assess local and sister sites’ quality final disposition of deviations, nonconformances, change controls, and lab reports.• Maintain electronic and non-electronic records for all finished good batch records received.• Perform review of and prepare Certificates of analysis and Certificate of compliance.• Initiate and communicate non-conformances, deviations, and OOS discovered during reviews. • Analyze laboratory results to verify they meet specifications and product specs and comply with test methods and release documentation.

• Assist in managing the daily operation of QC Lab functions along with supervision, training, and evaluation of QC Lab Technicians.• Review production batch records for accuracy and completeness before performing preliminary testing.• Reviewed final analytical data to ensure completeness and adherence to SOP/Specification following the completion of the quality control (QC) laboratory test by the technicians.• Collected DI water samples quarterly for 3rd party Total Organic Carbon testing.• Responsible for managing the department's stability program by requesting samples, delegating testing, reviewing results, and generating monthly reports for stability testing.• Charged with monitoring/verifying environmental temperature/humidity charts daily.• Generate Certificates of Analysis, initiate Non-Conformance Event Notice forms (NCEN), and participate in the investigation.Order laboratory supplies/uniforms as needed.• Support all levels of management set schedules and meet deadlines.• Monitor logbook/ Trends of daily product testing and ensure instrument maintenance/calibration is performed at required intervals.• Update quality procedures and stay current with applicable rules and regulations.