Regulatory Quality Programs

QA Manager of Chemistry and Chemical Engineering Division and Management Representative for ISO 9001:2015 Accreditation and Quality Management system. Responsibile for the Quality Management System as the umbrella for 15 regulatory programs to include: ISO 13485 Certification, 21 CFR Part 820; NELAC Certification, ISO 17025, ISO 17020, NQA1, Good Laboratory Practice for 21 CFR Part 58, 40 CFR part 160, 40 CFR Part 792, Good Manufacturing Practice 21 CFR part 210 and 211, DEA regulations 21 CFR Part 1300 to 1399, DOE QSAS, HAZQARD, NQA1, NRC. NUPIC, and USDA Permit. Responsible for internal and external audits for multiple regulatory programs and gap analysis for the listed regulatory programs.Develops and implements training programs for Ethics, and regulatory programs for ISO 9001, 17025, 13485, 21 CFR Part 820, GLP, cGMP, Controlled Substances, Data for legal defensibility, Environmental Sampling Issues, Employee compliance training, Quality Tools, and The QA Professional. Performs external audits for GMP/GLP/Medical Device facilities for approved suppliers, regulatory compliance, and gap analysis. External audits with lead auditor training in ISO 9001, ISO 17025, ISO 17020 and NQA1. Performed external audits for laboratories performing EPA work.Develops presentations and training workshops for the QA Professional, Ethics, GMP, GLP, Medical Devices, Environmental programs for legal defensibility, field sampling for NEFAP, laboratory compliance for NELAC, Quality Tools, and the QA Professional as well as other designed trainings.

Developed and implemented programs for water systems, chemical analysis, time study, work orders, administrative procedures, and preventive maintenance in the laboratory and inspection area of the quality departments at GenCorp. Planned, organized, and evaluated laboratory analysis of raw materials and finished specification requirement for rubber technology, and water systems against quality standards at to improve the product and its performance in the field. Experience in the analytical area involved analysis of raw materials for rubber technology, bench scale testing, and wet chemistry analysis. Maintained product standards through plant-wide quality inspection of raw materials, product construction, and final preparation. Maintained analytical procedures and performed laboratory analysis of raw materials and simulated bench-scale preparations as a quality chemist.

Implemented programs for potable and recirculating water systems, chemical analysis of raw materials and manufacturing specificatons of finished product for inorganic analysis, and preventive maintenance in the engineering, maintenance, and quality departments for Anaconda Aluminum Company/Atlantic Richfield Company (ARCO). Planned, organized, and evaluated laboratory analysis of raw materials and water systems against quality standards to improve the product and its performance in the field. Experience in the analytical area involved analysis of raw materials for aluminum products, metals, and wet chemistry analysis. Maintained product standards through plant-wide quality inspection of raw materials, product construction, and final preparation.