Microsoft Word - SPDS_0918_ERP-Proposal-07-11-2018DMC

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parkmimi@optonline.net (Cell)201-926-9584

Mimi Park 62 Ross Ave., Demarest, NJ 07627 (Home)201-784-8206

Site Head Quality/Head of QA and Compliance/Director of Analytics and QC Highly effective and versatile professional with Director level management experience in many key areas of the Pharmaceutical and Nutraceutical industry. Skilled in developing methodologies and metrics to meet the demands of organizational changes .  Excellent knowledge of broad spectrum of QA, R&D and QC functions  Strong knowledge of FDA/ICH regulatory guidelines  Excellent leadership skills with capabilities to multi-task under time constraints Edu atio Stevens Institute of Technology M.S. Analytical Chemistry 1999-2004 Hoboken, NJ Boston University B.S. Chemistry 1981-1985 Boston, MA Professional Experience The Nature’s Bounty Company Ronkonkoma, NY Senior Manager , AR&D/Stability September 2017 to Current • Manages and supports the AR&D and Stability groups to maximize the capabilities to meet the global analytical and stability requirements. • Directs research activities to support product quality and manufacturing processes across the network. • Directs and proposes strategies in resolving global analytical issues and assists investigation activities at all network sites. • Set direction and strategy for how the stability program will be designed and executed to ensure that the Nature’s Bounty and its vendors/product portfolio will be compliant with FDA regulations and ICH guidelines. • Provides scientific leadership in the review of stability data reports and stability out of specification investigations to identify potential risks, root cause and provide recommendations on each product based on the stability profile. • Ensure that any information necessary for audit compliance is available for review and provide corrective and preventive actions on any observations for compliance issues. • Mentor and coach the AR&D and Stability teams in both technical and professional aspects to ensure competency growth. Quality Manager (Site Head Quality)-Solgar Vitamins April 2015 to September 2017 • Managed QA and QC operations for the site • Provided day to day leadership to the quality team in resolving quality related issues • Maintained and implemented site quality system for change controls, CAPA system, GMP deviations/Investigations, GMP audits, SOPs, validations, training program, etc. • Managed improvements for site key quality metrics (i.e. FPQ, Cycle Time, Consumer Complaints) • Led and participated in development and implementation of corporate quality systems • Led FDA and other client inspections and participated in internal and external audits