PROFESSIONAL SUMMARY Competent business professional that is well organized with a consistent track record of surpassing standards and goals in manufacturing support and inventory control. Easily establish rapport and confidence while building strong and lasting relationships with a diverse group of other professional disciplines and administrators. Possess exceptional planning, prioritizing and goal setting skills to achieve optimal outcomes. QUALIFICATIONS * Knowledge of FDA regulations 21 CFR parts 210 & 211, 21 CFR part 110 &111. * Knowledge of GMP, GLP, GDP and SOP as well as HACCP. * (IQ) Instrument Qualifications, (OQ) Operation Qualifications and (PQ) Performance Qualification. * Knowledge of OSHA regulations and Adhered to ISO 9001,14000. * Strong written and oral communication skills, detail-oriented. * Experienced in direct supervision for subordinates and their activities. * Intermediate skills at using various Microsoft office tools to prepare documents. Experienced with Quality Management Systems. * Experienced in creating and revising departmental work instructions, Sops, Test Methods, and Forms. * Excellent interpersonal communication skills and comfortable working with diversity. * Excellent organization, problem-solving, and troubleshooting skills. Weigh Communicate with management and other department heads to coordinate Quality Assurance activities within departments. Provide direction and lead the development and implementation of Quality Management Systems that meet company, customer and regulatory requirements. Provide technical support to the Quality Control operation, support to programs aimed at the improvement and creation of Quality documentation. Lead in communication with suppliers on quality issues, product specifications, component quality issues and specification, provide scientific and technical support to management, development of continuous Quality System improvement programs. Review and approve lab reports, validation reports, stability reports, production documentation and specifications to ensure compliance with company, customer and regulatory requirements. Coordinate the Corrective and Preventative Action Program, perform investigations, prepare investigation reports and submit findings to management. Coordinate the Standard Operating Procedure program and review and approve associated documentation. Maintain quality system reports and prepare quarterly reports for Senior Management. Conduct internal audits and third-party supplier to assure compliance with the Quality Management System. Handle the control of all non-conforming products including third party suppliers and assists in the coordination of company-wide Good Manufacturing Practices (GMP) and International Organization for Standardization (ISO) training. Issue Non-Conforming Materials Reports (NCMR) from Compounding, Production, QC Lab, or Incoming Inspection and log the (NCMR) into the database in Microsoft Access. Communicate with management during Material Review Board (MRB) meeting for the disposition of the non-conforming product. Enter the disposition into the Non-Conforming Material Report (NCMR) database including method of destruction and cost of product loss (if applicable). Complete and follow-up on (NCMR) Return/Reject reports, Supplier Corrective Action Reports (SCAR), Material Destruction Records (MDR), and Deviation notices. Forwards NCMR to accounting, purchasing, inventory, and production to ensure non-conforming product is returned to supplier or destroyed. Responsible for the completion of Root Cause Failure Analysis and Investigations. Ensure compliance of the Quality Management system and Current Good Manufacturing Practices (cGMP) by conducting internal audits for both GMP and ISO. Ensure compliance with the company's Supplier Quality Management System by sending out questionnaires to suppliers, evaluate and conduct supplier audits when required. Create quality documents by writing new procedures and designing quality forms, train department personnel on specified procedures and forms. Ensure compliance with company Quality Management System and current Standard Operating Procedures (SOP) by conducting internal audits for Good Manufacturing Practices (GMP) and International Organization for Standardization (ISO) and conduct companywide training. Account for raw material inventory by working with vendors to communicate quality and delivery issues, handle customer complaints by collaborating with production engineers to identify and solve issues. Review engineering drawings and process specifications to inspect and determine requirements for inspection of components, performed incoming inspection of material receipts for a wide variety of components including hardware, and electronic assemblies. measure and mix raw materials used in bulk batch manufacturing operate process equipment such as pumps mixers mills and kettles equipment set-up and change over for sanitation and sterilization of process. Inspection of production process and perform in process checks of tablet compression granulation and weighing of components. Review of production and packaging records for completeness and (cGMP) compliance calculation accuracy for predetermined standards.
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