Provides Quality Assurance support to Technology Transfer, Metrology and Quality Laboratory departments; Reviews and Approves Validation protocols for compliance with regulatory and standard operating procedures. Reviews and Approves of QC Chemistry testing data, OOS, and OOT investigations. Audits stability data for commercial and exhibition lots. Reviews and Approves Equipment Qualification (URDS, IQ\OQ\PQ).Duties include; Creation and Revision of SOP’s, review and approval of updates to SOP’s, Specifications, and Test Methods. Managed the completion of process improvement projects (ADE Cleaning limits, Cross Contamination Risk Assessment).

Responsible for working with Contract Manufacturers; ensure batch manufacturing compliance and management of complaint investigations.Duties include; Reviewing of CMO batch records, CoA’s, deviations and investigations. Revision of SOP’s, creation and execution of Mitigation Plans and Corrective Actions. Responsible for site Deviations, Investigations, and Metrics. Drafting of Quality Agreements and FDA Field Alert Reports for Sr QA Director. Management of continuous improvement projects (ID Testing and Temperature Monitoring). Interface regularly with CMO Quality Groups, Supply Chain, Corporate QA Compliance, and Regulatory Affairs.

Responsible for assuring the quality of laboratory procedures, data and reports by evaluating for compliance with analytical methods, protocols, standard operating procedures and applicable FDA regulations. Tasks performed include; Review of analytical data, reports, protocols, and methods. Audit of equipment qualification, computer validation, and general laboratory records. Perform in-process, general facility, vendor, and subcontractor laboratory inspections. Performed both GMP and GPL inspections.Accountable for the preparation of reports of audit findings, scheduling and conduction follow-up inspections as needed, and assisting with client audits, regulatory inspections, employee training, and the development of quality systems.

Responsible for assuring the quality of laboratory data and reports for compliance with protocols, methods and standard operating procedures.Review of Validation protocols, methods, and data for compliance to ICH guidelines and FDA regulations.Conducts inspections of laboratory personnel, training records, equipment qualification, general facilities, and vendor/sub-contractor compliance.Review of Investigations, Deviations, Corrective and Preventive actions, and approval of extensions. Accountable for assisting with client audits, regulatory inspections, employee training, and the development of quality systems.