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K. Nicole Harter
Objective |
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To lead a Quality Assurance team, reviewing and auditing documentation and product specifications for technical accuracy and FDA compliance. |
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B.S., Chemistry Indiana University, Bloomington, IN May 1995 Coursework included Honors Chemistry. |
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Quality Control Laboratory Leader Eli Lilly and Company, Indianapolis, IN January 2004 – July 2005 · Supervised analysts for in-process insulin. While on staff, revised all major analytical methods to streamline processes, improve executability, and increase compliance.
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Quality Control Manager Blairex/Applied Laboratories Inc., Columbus, IN July 2001 – October 2001 · Responsible for all QC functions at Blairex. Control all cGMP documentation for facility.
· Developed system to reduce quarantine time by up to 50%. |
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Reference Standard Schwarz Pharma Incorporated, Seymour, IN October 1997 – July 2001 Coordinator, Chemist · Reduced costs and utilized all QC departments to minimize testing time. Revised SOPs for standard qualification; reorganized system for greater efficiency. Annual cost savings of over $7,000. · Reviewed and corrected over 60 SOPs, GMs, and Cleaning Validation protocols. · Oversaw all water sample investigations for entire facility. Validated two new water systems; authored change to reduce testing costs by over $25,000 annually. Implemented improvements to European facility’s systems and documentation, including training personnel. Affected cost savings of approximately $20,000 annually for that facility. · Worked in the In-Process lab, met short timelines and improved customer satisfaction in manufacturing. Involved in learning production of materials and auditing of manufacturing rooms. |
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Chemist Cargill Incorporated, Memphis, TN August 1996 – September 1997 · Team Leader. Conducted all team meetings and increased team efficiency through job sharing.
· Negotiated agreements with external suppliers. Reduced purchase costs by 25%.
· Served as liaison between manufacturing department needs and FDA concerns.
· Developed and assigned specifications for a new method for testing chlorides for new hypochlorite supplier.
· Head of Flavor Panel and Starch Price of Non-Conformance teams. Developed method to decrease bias present in panel results. Reduced cost of production by over 15% in 10 months |
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Chemist Universal Flavors, Indianapolis, IN December 1995 – July 1999 · Modified product flavor content based on customer requests and feedback. · Distinguished flavoring differences with nearly 100% accuracy in double-blind studies. · Revised storage system and documentation procedure for prepared samples, flavor, and raw material usage. Increased efficiency by 10%. Improved formulation miscibility; prevented an estimated loss of $8,000 annually. |
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· Board of Directors, Columbus Indiana Ecumenical Council · Chairperson of Buildings and Grounds Committee, Columbus Love Chapel Food Bank · Volunteer, Cincinnati Zoo and Botanical Gardens, Manatee Exhibit Maintenance · SCUBA diving – Advanced Open Water Certification · Salt Water and Fresh Water Aquariums |
Our search firm is currently representing a mid sized compound flavor manufacturer in need of a Manager – QA/QC. 4 direct reports. Significant compensation, relocation, etc. etc.
West Coast headquarters.
Please advise if you are available and interested to have me contact you with particulars.
Larry Hersh
Ebel-Hersh & Associates
(386) 676-2175