SPDS ERP Review-May 2015

KELLY LYNN REINS 837 Kallin Ave Long Beach, CA 90815 Kelly.Reins@gmail.com mobile 562.754.2928

SUMMARY

Quality Professional professional with extensive experience in manufacturing and laboratory operations in the pharmaceutical and dietary supplement industries. Expertise in manufacturing, quality systems, 21 CFR Part 110, 111, 211 and 11 cGMP compliance, and Pharmacopeial monographs. Key strengths include managing quality systems for compliance with cGMP, managing complex projects, resources, and troubleshooting. Solid background in auditing, laboratory instrumentation, training personnel, and electronic documentation systems.

PROFESSIONAL EXPERIENCE

ALKEMISTS LABORATORIES Costa Mesa, CA Private, contract testing laboratory of natural products, herbal medicines, and dietary supplements VP Operations & Quality 2013- 2014 Oversaw the Company Operations and Quality aspects for compliance with 21 CFR Part 111, 211 and ISO17025. • Expanded lab to handle high-end analytical work. Responsible for procurement of state of the art instrumentation. Water UPLC, HPLC, Microbalances. • Provided technical support for the overhaul of the documentation, training and overall quality systems. • Authored companywide SOPs for ISO17025 compliance. • Oversaw the design of method feasibility, verification, and validation studies for Clients per USP/ICH guidelines. • Provided technical expertise to Clients regarding cGMPs requirements, experimental design, CMC documentation requirements, and deficiency/warning letter responses. • Provided training for safety, cGMP and ISO17025. • Served on the Executive Leadership Network group, working with industry and the FDA to draft industry guidance for compliance with the Scientifically Valid method requirement. Executive Director, Laboratory Operations and Compliance 2010-2013 2009 - 2010 Private, global mass-market contract manufacturer and distributor of dietary supplements Director, Quality Control Oversaw Quality Control staff of 28 members. • Authored and revised laboratory Standard Operating Procedures for compliance with 21 CFR Part 111. • Proved support for master manufacturing and batch record review. • Expanded laboratory size, staff, and instrument capabilities: Waters HPLC/UPLC, UV/VIS, Rapid Micro Detection Systems. • Monitored the method verification and validation program for compliance with 21 CFR Part 111. • Oversaw the stability program and the installation of a walk-in stability chamber. • Worked with purchasing to ensure raw material were purchased against approved specifications. • Served on the safety committee to ensure compliance with State, Federal, and company requirements. ROBINSON PHARMA, INC., Santa Ana, CA