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Quality Manager or Lab Manager

Quality Manager or Lab Manager

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Published by api-77590287
Quality Manager, Lab Manager with 5 years experience looking for a Middle Management position.
Quality Manager, Lab Manager with 5 years experience looking for a Middle Management position.

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Published by: api-77590287 on May 28, 2011
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05/12/2014

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Jane Parks1896 Mignon Avenue, Memphis, TN 38107 jp7d8054@westpost.net 901.355.1389Summary For over 20 years, I have held positions of increasing responsibility within highly regulated environments. My experience is diverse and includes directexposure with USDA, FDA, cGMP, ISO, and customer's quality requirements. I haveworked in a variety of functions within a single job title, responsible for Quality Systems and Regulatory Compliance, always with a firm belief in continuousimprovement. I have excellent communication and analytical skills, enabling me to work well in a technical environment, as well as interface effectively with cross-functional quality teams. Experience QA Laboratory ManagerJune 2005 - Present KIK Custom Products, Memphis, TNManage the Quality Assurance Laboratory, overseeing the Quality Systems and requirements of a manufacturing plane of 350+ employees.Conduct cGMP / Quality Audits monthly and work with cross-functional teams to ensure Quality Management goals are being met.Train, manage, and develop quality personnel to operate in compliance with cGMP/ FDA Regulations.Provide technical support, making specific recommendations as to the testing and adjusting of raw materials and bulk formulations.Maintain the department to comply with GMP, USP, and the customer's quality specifications.Validate new analytical methods, and write/update SOP's as needed.* On call 24/7 to provide quality and technical support for the laboratory, compounding, and production.Assist with investigations of OOS raw materials/finished product, helping to develop corrective and preventative actions.Interface with customers to resolve quality issues, specification changes, andprovide technical advice.Oversee/perform calibrations, maintenance, troubleshooting of laboratory instrumentation.Train entry-level laboratory technicians and chemists in methods and hands-on training in GC, HPLC, UV-VIS, FTIR, and Viscometers. Laboratory ManagerJanuary 2003-June 2005 Anresco, Inc., Fort Lauderdale, FloridaPrimarily responsible for all aspects of the daily operation of an agriculturaltesting lab.Interface with clients, and schedule sampling for the FDA detention samples.Responsible for laboratory safety and health, as well as safe and legal disposal of laboratory wastes.Responsible for interviewing, hiring, and training of new employees.Responsible for maintenance, troubleshooting, and repair, whenever possible, onlab equipment.Provided customer contact, as well as acted as a liaison between our clients and the FDA.Performed and supervised HPLC, GC, and GC/MS assays for pesticide residues andmycotoxins.Prepared packets for samples on automatic detention to be submitted to the Atlanta and Miami offices of the FDA, becoming the "test lab" for submitting the packets by electronic submission. Chromatography Laboratory ManagerOctober 1996-January 2003 CII Laboratory Services, Kansas City, MO

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