● Provided QA Review and approval of SOP’s, Deviations, CAPA’s, Damaged and Defective Raw Materials, and Lab Investigations. ● Reviewed and approved updates to GMP documentation including Master Batch Records, Logbooks, Raw Material Specifications and Raw Material Risk Assessments.● Maintained site audit readiness by performing monthly walkthroughs.● Provided quality oversight of manufacturing operations through QA On-the-Floor Program. ● Reviewed and approved work orders in Infor CMS for site Maintenance and Facilities team.● Performed batch record review of Bulk Drug Product Manufacturing operations, ensuring all steps have been executed correctly and GDP is followed by Manufacturing.● Collaborated cross-functionally with QC, Materials Management, and Manufacturing to achieve on-time delivery of Quality System records. ● Responsible for the disposition of Bulk Drug Products in inventory using SAP Quality Module.● Executed inspection management activities to support partner audits.

Performed consistent quality batch record review to ensure all steps have been executed correctly and GDP is followed by Manufacturing Collaborated cross-functionally with QC and Manufacturing through coordinating testing and manufacturing review of batch records to meet shipment demands.Reviewed required QC tests per corresponding product lots such as Bioburden/Endotoxin, HPLC, and SDS-Page, and verified that all specifications were met prior to releaseIdentification of process deviations, including Out-of-Specification results.Responsible for batch disposition in inventory using SAP.Initiated, managed, and approved unplanned deviations, planned deviations, and corrective actions. Certified ISO-9001 Lead Auditor, assisting on internal audits.Assisted with maintenance and continuous improvement of the Quality Management System through CAPA’s (e.g GDP training). Maintained records in keeping with ISO-9001 Guidelines.Reviewed and maintained detailed Environmental Monitoring and RODI Collection Data.Responsible for investigating, reporting, and assessing possible deviations of temperature excursions for freezers storing product.Label verification.

Assisted Production: check in process products for conformance to specification (salt, acid, pH, brix, color, viscosity, texture, etc.); made adjustments when necessary. Enforced adherence of employees to cGMP and SQF guidelines.Conducted HACCP checks during filling and pasteurization of products.Performed environmental swabs as part of our Environmental Monitoring Program, as well as ATP swabs. Skilled with using company HOLD documentation systems, conducting internal investigations, and documenting findings.Performed daily facility inspection, monitored equipment, approved work orders and signed off on them. Conducted monthly audits of the facility. Maintained records of GMP, SOP, and HACCP documentation for both internal and external audits.Participated in review and revisions of standard operating procedures.Supported the Quality Assurance Team with Customer Complaints. HACCP Certified Individual as of 12/10/2019.Performed data entry using Word and Excel documents.Conducted day to day lab management, maintenance of equipment and inventory.