Conduct routine and non-routine analyses of in-process materials, raw materials and finished goods. Interpret test results and compare them to the specifications and determine the disposition of the material. Keep the sample log and send samples to customers as requested. Compile laboratory test data and prepare weekly reports. Develop, review and revise procedures, forms and documentation related to operations. Prepare and send to the customer regulatory documentation. Scan into the company drive documents related to the products manufactured. Perform laboratory equipment maintenance.

Supervise the activities of the Quality Control Group in the performance of their tasks. This includes schedule within the staff of QC technicians and QA inspectors, microbiologists and a Chemist the components, raw materials(including water) and finished good testing (including microbiology, stability and label claim). Assists in resolving quality issues in the laboratory and the production areas. Perform out of specification, NCR, CAPAs, deviations and customer complaints investigations. Develop and review SOPs. Assist management during internal and external audits. Periodically assume the role and responsibilities of the Quality Manager.

For a Medical Devices Company manages all aspects of the Quality Control and Quality Assurance. This includes Quality Manual review and update for ISO 9001/13485 certification. Also develops procedures, forms and related documentation for Manufacturing, Packaging, Purchasing and Warehouse. Performed Raw Materials, Packaging Components and Assembly goods incoming inspections and Approval. Assist the Regulatory representative in customer audits.

QA/QC Laboratory Supervisor: Supervise the daily operation of the Quality Control Laboratory and Quality Assurance Group. This includes scheduling within the staff of seven QA/QC technicians the incoming material inspection and testing. Following up on assigned samples/tasks based on communicated priorities with other departments. Conduct investigations for out of specification results. Documentation review, procedure (SOP) development and update. Coordination with production, warehouse and sales/planning product releases.

For a production line of 20 employees, managed all aspects of production, including: scheduling, forecasting, training, documentation, atypical investigation, corrective actions, SOP’s, MPD’s, special instructions, cleaning and new product introduction validations.