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Quality Assurance Manager

Greenwood, Indiana, 46142, United States
December 10, 2010
Contact Info:


*** ********* ***, *********, ******* 46142

Home: (317) ***-**** Cell: (317) *** ****



Cost conscious and analytical with history of success

Optimizing quality and efficiency in fast paced manufacturing environments

Over twenty years of professional career highlighted by increasing laboratory productivity and quality of products through keen data analysis and Six Sigma projects. Successful in improving laboratory efficiency and providing timely resolution to manufacturing issues. Proven ability to identify opportunities for enhancing safety standard and maximizing ROI on capital budget. A creative thinker, problem solver and decision maker. Strong interpersonal relations, mentoring and cross-functional team management skills. PC proficient in Word, Excel, PowerPoint.

Areas of Expertise

Technology Management – Analytical Chemistry – Third Party Operation Auditing

Quality System -- Quality Control – Cell Bank Quality – Compendia Review and Evaluation


Consultant Chemist 06/2007 – 11/2010

Eli Lilly & Company -- Indianapolis, Indiana

Functioned as Technical Manager and frontline QC technical resource for the Central Services and Biosynthesis Human Insulin laboratories (30 analysts and 24-hour support). Recognized as a subject matter expert on increasing laboratory productivity and resolving manufacturing issues while reducing costs and maintaining safety in a large Pharmaceutical manufacturer. Led Six Sigma projects to reduce NVA activities and deviation issues. Provided ongoing production support and troubleshooting. Participated in Regulatory Agency inspections and guided auditors in TPO audits. Mentored and coached QC personnel on technical issues.

Selected Contributions:

• Reduced the deviation rate by 75% through internal training efforts and coaching QC representatives in quality-based services.

• Delivered over $200K savings in waste reduction and neutralization.

• Eliminated NVA activities which increased lab efficiency by 50% through the use of statistical process control charting.

Responsible Scientist 07/2002 – 06/2007

Eli Lilly & Company -- Indianapolis, Indiana

Responsible Scientist for Antibiotic, Water, Fermentation Biosynthesis laboratories. Provided complete technical oversight for analytical investigations and laboratory change control/Batch Record approval. Held full responsibility for advising QC on quality issues/corrective actions and interacting with TPO on outsourcing project.

Selected contributions:

• Directed the IBO Responsible Scientist group in response to FDA consent decree to achieve consistent practice throughout IBO organization.

• Led the technology transfer project to completion to transfer Antibiotic products to TPO.

• Coordinated QC/QA efforts resulting in net reduction of deviation backlog from over 260 to less than 5 within four months.

Associate Quality Consultant 04/2002 -- 07/2002

Eli Lilly & Company -- Indianapolis, Indiana

Created and maintained Q system for Development Cell Bank. Responsible for QC of Bio-Research and Development laboratories. Audited TPO including manufacturing evaluation and qualifying vendors. Conducted review and approval of all laboratory IQ/OQ, method validation and method transfer. Mentored new QC representatives.

Selected contributions:

• Reviewed and approved the first Commercial Mammalian Cell Bank including reviewing, approving testing protocols and testing results.

• Established a defined SOP for quality control of development and Commercial Cell Banks.

• Implemented in-house IQ/OQ process to lower costs.

Senior Quality Control Representative 03/2000 -- 04/2002

Eli Lilly & Company -- Indianapolis, Indiana

Performed internal and external quality audits. Quality control representative for early phase development laboratories (Bio and Chemical Research development). Created a Q plan for site laboratories and conducted follow-up reports. Established plan in place for PAI readiness.

Selected Contributions:

• Led the review process and interacted with TPO to conduct audit on Radiochemical lots used in Toxicology and metabolism studies.

• Created a defined SOP and established Quality Agreements with TPO to prevent quality issues in the downstream process development.

Analytical Chemist 11/1995 -- 03/2000

Eli Lilly -- Indianapolis, Indiana

Site representative for the corporate compendia review team and served as site coordinator for the global bulk residual solvent project. Performed periodic product quality review for bulk pharmaceutical products. Directed other team members and coordinated new product’s method transfer project. Served as trouble shooter in method improvement services.

Selected Contributions:

• Implemented the new instrument part to replace the cold trap in GC analysis of Nitrosamines gaining six hours of analyst’s time per day. This effort saved approximately $300K for the first year and continued to provide savings up to now.

Control Scientist II 01/1992 -- 11/1995

Burroughs Wellcome Co. Greenville, North Carolina

Promoted to Group Leader in QA laboratory to lead five chemists and responsible for the analysis of raw materials, intermediates, and final drug substances. Also promoted to Group Leader in manufacturing with full technical responsibility for production and engineering project team. Performed annual product review and provided critical data for submission to regulatory agency. Reviewed and approved SOP’s, changes to process master formulas.

Selected Contributions:

• Accomplished lab scale process to produce reference standard materials to the USP. Completed the project on time without issues.

Control Scientist I 01/1990 -- 01/1992

Burroughs Wellcome Co. Greenville, North Carolina

Performed stability control testing (including both scheduled and accelerated studies) for intermediates and final bulk drug substances to establish impurity profiles and projected expiration date for product submission.

Laboratory Analyst II 02/1988 -- 01/1990

Burroughs Wellcome Co. Greenville, North Carolina

Conducted dissolution testing to determine the content uniformity for solid dosage forms and performed stability testing on final pharmaceutical products.


Laboratory Assistant 05/1987 -- 12/1987

University of Illinois. Urbana-Champaign, Illinois

Performed BOD, COD and gas analysis on environmental samples.

Student Assistant 03/1983 -- 12/1984

Carl Sandburg College Library. Galesburg, Illinois

Chief Of Information Section At The Refugee Camp 07/1981 -- 09/1982

Pulau Galang Refugee Camp. Galang, Indonesia


University of Phoenix

MBA/Technology Management 01/1999

University of Illinois

BS/Chemistry 12/87

Western Illinois University

Attended 01/85 to 06/85

Carl Sandburg College

AS/General engineering 01/85

Professional Development

• X-Ray Powder Diffraction, X-Ray Fluorescent: trained by the International Center for Diffraction Data.

• Advanced Capillary GC Technique and Trouble Shooting: American Chemical Society.

• Advanced HPLC Method Development and Trouble Shooting: L.C. Resources.

• Certified Quality Auditor: Burroughs Wellcome site training and development.

• Grid and Grid Work (functional work team): Burroughs Wellcome site training and development.

• Problem solving and decision making: Burroughs Wellcome site training and development.

• Leadership Training for Technical Personnel: Burroughs Wellcome site training and development.

• Scientific Writing: Burroughs Wellcome site training and development.

• The Seven Habits of Highly Effective People: Eli Lilly and Company (Covey Leadership Center).

• Interaction for Effective Leadership: Eli Lilly and Company.


Member of P.T.K. Member of Who’s Who Among American Junior College Students. President of V.S.A. at U.of I. From 6/85 to 12/87. Coordinator of V.S.A. in central Illinois from 6/85 to 12/87.

Certificate of Merit from the United Nation High Commissioner for Refugees and the Indonesian Red Cross for volunteer work at the refugee camp (1982). Outstanding service award (1984). Perfect attendance awards (1988 to 1995). Excellence awards (1988 to 1995).