Resume

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K. Nicole Harter

Objective

To lead a Quality Assurance team, reviewing and auditing documentation and product specifications for technical accuracy and FDA compliance.

B.S., Chemistry Indiana University, Bloomington, IN May 1995

Coursework included Honors Chemistry.

Quality Consultant Eli Lilly and Company, Indianapolis, IN March 2007 – present

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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.

Director of Quality Control Blairex/Applied Laboratories Inc., Columbus, IN October 2001 – 2004

· Direct all Quality operations for both facilities. Reduced laboratory costs and implemented interdepartmental training. Lead all phases of external and internal audits.

 

· Developed new training program for laboratory employees. Implement new, clearer documentation for incoming lab personnel. Reduced personnel turnover by 20%.

 

· Critiqued water system and improved sampling procedure to reduce the errors reports by 75%.

 

· Improved the level of cross-training for each job function to provide greater opportunity for QC employees.

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%.

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.

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

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.

· 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