• Responsible for managing and maintaining change control process.• Performed editing and distribution of Standard Operating Procedures.• Conducted and performed evaluations of Approved Suppliers.• Responsible for scheduling and conducting internal audits.• Assisted with product registration as per FDA requirements.• Provided assistance with CAPA related investigations.• Processed Non-Conforming Material Reports (NCMR’s).• Generated quarterly metric reports of quality related (KPI’s).• Assisted management with compilation of Management Review Meeting materials.

• Maintenance and control of all electronic and non-electronic documents within QA, including but not limited to Master Batch Records, and Bulk / Raw Material specifications. Ensuring proper formatting is followed for the various QA documents.• Prepare Quarterly Metric Reports of Key Performance Indicators (KPI’s).• Project management of the approvals of change control requests and Master Batch Record approvals as it relates to Research and Development. Monitor, expedite and track the timely execution of Product Quote Requests by the QA Scientists and Assistant Scientists.• Data entry of new formula and revisions to Master Batch Records under the direction of the QA Scientist or QA Assistant Scientist. Process various forms and reports including data entry on general information spreadsheets, laboratory databases, etc.• Interact with Research & Development, Quality Control, Procurement and Nutrition Department to ensure the distribution of revised and needed documents in a timely manner.• Perform special projects as may be assigned by the QA Document Control Manager/QA Manager or QA Director.

• Responsible for the collection of public record court related documentation.• Perform research task to acquire client requested public documents.• Maintain categorized listing of document projects.• Performed document verification and collection in various county courthouses.

• Responsible for the management of electronic quality management system.• Managed change control process for all departments company wide.• Performed initiation and revisions of Standard Operating Procedures.• Responsible for ensuring implementation of appropriate document formatting.• Performed Biennial documentation reviews of top level quality procedures.• Managed and maintained Approved Supplier Process, including ongoing evaluations.• Provided assistance in quality data report compilation for management meetings.• Generated metric reports focusing on quality key performance indicators.• Assisted in the review of process and product validation documentation.• Managed and maintained employee training records via electronic format.• Assisted with investigations to resolve customer complaint issues.• Managed and processed CAPA investigations.

• Coordinate the document change control processes that involve the receipt, maintenance, approval, distribution, maintenance of electronic files and storage of documents to include, but not limited to: batch records, standard operating procedures, protocols, deviations, investigations and standard forms.• Assure that any data tracking systems are kept current and are operating as efficiently as possible. Monitor progress of documents under change control revision, and generate necessary reports.• Assist in coordinating the Document Approval Process involving answering inquiries made by authors, reviewers and approvers.• Support the Personnel Qualification System, provision of new full-time Orientation and maintenance of personnel training records.• Assignment of document codes to specified GMP records (i.e. SOPs, STPs)• Managed, maintained and updated employee training record system as required.

• Managed change control process for all departments company wide.• Responsible for ensuring implementation of appropriate document formatting.• Distribution of newly effective controlled documents to appropriate locations.• Administration of change control system.• Responsible for performing Annual Product Reviews.• Maintain and control all electronic files of controlled documentation.• Issuance and tracking of batch production records.• Assist with documentation reviews.• Managed and processed CAPA investigations.• Maintaining retention files to facilitate document organization and retrieval.• Responsible for requalification of approved vendors.

• Managed substandard material report (SMR) process to ensure that materials deemed substandard were identified, segregated, and removed from inventory.• Conducted thorough and comprehensive investigations in conjunction with suppliers of substandard materials.• Served as the chairperson for Material Review Board (MRB).• Responsible for the release of raw materials for the production of pharmaceutical grade prescription drugs. Database management in Access and SAP.• Reviewed all pertinent documentation regarding specified materials, including certificate of analysis, manufacturing licenses, government approved narcotic certificates, but not limited to analytical test results.• Managed and processed CAPA investigations• Prepared monthly metrics reports for management teams for trending analysis.• Managed and maintained all files related to vendor supplied materials.• Responsible for writing and revising Standard Operating Procedures.