Quality Manager

DANIEL MARK WAITE

W**** Cottonville Court • Wautoma Wisconsin 54982 • ***************@*******.*** • 920-***-****

Senior Associate

Quality Assurance • Research • Laboratory Management • Operations

An accomplished and distinguished Manager and Senior Associate for both startup and growth organizations. Executed projects in the manufacturing, quality, environmental, pharmaceutical, and R & D laboratory setting. Results oriented with proven success providing your company strong problem solving capabilities drawn from a wide array of sciences and quality regimes. Proven track record of providing valuable insights and innovative solutions incorporating a strong attention to detail. Charged with reducing operation costs increasing bottom line through process and quality improvements.

Core Competencies

• Analytical Scientist- NMR, GC, HPLC, MS, UV/VIS, TLC, ICP, AA, Gel Electro., Micro, Fluorescence, 96 well plate reader, Elisa, TOC. Formulations/Deformulation.

• Operations Management experience responsible for budget, schedule, safety and OSHA compliance, HAACP analysis ,cGMP compliance

• Vendor Qualification/ Lead Auditor/ Client Liaison

• Validation/ IQ,OQ,PQ

• Lean Manufacturing/JIT principles/ Procurement

• Proven leadership skills and the integrity to build, train, lead, delegate, and mentor highly productive and motivated cross functional teams involved with highly sensitive projects and multi million dollar long term stability studies.

Perspective

Analytical Chemist and Quality/Operations Manager with a unique blend of business management. 20 years of experience in a FDA/cGMP and cGLP quality setting. My keen insight to quality objectives and in depth knowledge of improving operations will enable me to impact your bottom line. A career long history of consistently increasing productivity and reducing costs. Recognized as an accomplished consultant, skilled at providing effective technical instruction and coordinating training and safety programs. Adept at conveying even the most technical and complex information to chemists and clients alike at all levels. I am confident my combination of drive and experience will provide you with an invaluable resource.

DANIEL MARK WAITE • PAGE 2

Professional Experience

New Life Nutrition, LLC Coloma, Wi. August 2007 – Present

Quality Manager

Hired to initiate all aspects of a startup, FDA regulated Nutraceutical company. Setup/qualified vendor accounts. Perform cost reduction analysis and negotiate all pricing. Maintain company inventory database. Author of all SOP’s, GMP protocols, MMF records, product specifications, as well as provide all company, quality, safety, and fire training on an ongoing basis. Hired as Quality Manager to retain existing business, expand client database, and prepare company for first FDA 482 Inspection. Lead quality program with third party laboratories performing analysis on all raw materials, in process, and finished products.

Atrium, Inc. Wautoma, Wi. October 2005 – 2007

Laboratory/Operations Manager

Facilitate all aspects of a fast paced FDA regulated Nutraceutical company. Direct all production activities on a daily basis, from the receiving of the raw materials, to signing of the bill of lading to ship my clients their products. Perform cost reduction analysis and initiated a quality improvement plan resulting in extensive cost savings. Maintain company inventory database. Author of all certificates of analysis and MSDS database for the products produced as well as provide all company, quality, and OSHA, safety, and fire training on an ongoing basis. Hired as Laboratory Manager to construct an FDA approved lab.

Zystor Therapeutics, Inc. Milwaukee Wi. Jan 2005 - Sept 2005

Laboratory Manager/Protein Purification Scientist, Start Up Company

Hired to setup a complete research facility for a St. Louis based genetic research company at the Milwaukee County Research Park. Installed all equipment moved to the facility, and purchased and installed all remaining equipment. Maintained all DNA and protein cells in a cryogenic atmosphere. Ordered all laboratory supplies while negotiating all pricing. Performed protein purification on protein cells derived from children with fatal genetic diseases. Compiled researcher’s data for expression to investors.

The Triad Group Milwaukee Wi. Sept. 2004 - Dec. 2004

Contract Laboratory Manager

Hired as Laboratory Manager to construct an FDA approved lab. Responsible for all duties associated with a FDA regulated medical device, pharmaceutical, and contract manufacturing facilities QA laboratory requirements. Released all finished products and raw materials under cGMP and cGLP conditions. Source and purchased chemicals, lab equipment, and outside services. Maintained and initiated stability studies. Finalized OOS and NCM reports, and authored CAPA reports based on the findings. Trained analyst in cGLP/cGMP techniques, and updated all testing performed to the current version of the USP. Utilized SPC database to set all product specifications based on historical data.

Covance North America, Madison Wi. Nov. 2003 - Sept. 2004

Senior Research Associate.

As a Senior Research Associate in the pharmaceutical development and analysis division, I was responsible for developing assays under USP/EU/cGMP/cGLP guidelines for major long term stability projects. Methodologies incorporated the use of HPLC, LC/MS, GC, and GC/MS. As a senior member of the pharmaceutical analysis team, I facilitated the training of research assistants and analysts in all assays, and modified and developed assays for feasibility studies. This helped project managers bid properly on incoming work, so accurate timeframes and scheduling may take place. Audited analysts work for completeness and accuracy, and maintained the audit trail through completion.

Pierce Milwaukee, LLC. (Pharmacia Biotech) Milwaukee, Wi. Oct. 1997 - Nov. 2003

Senior Chemist.

Performed quality control assays for the Nucleotides/Triphosphates division, as well as method and instrument validations as a production chemist. Promoted to Senior Chemist July 1998. Added duties included equipment maintenance/troubleshooting, and method/SOP writing and revising. Led various research projects working closely with project mangers. Sept. 1998, initiated cross training of other chemists for this testing and took over the companies Amidite QC testing as well. January 2000, began validation of the companies NMR imaging instrument to perform QC, in process, and R & D analysis for H1 and 31 p NMR samples. Completed validation of HPLC/MS equipment.

Aldrich Chemical Company Sheboygan Falls, Wi. July 1997 - Oct. 1997

Contract Production Chemist.

Performed analysis on various chemical, solvent, and experimental materials for purity and stability purposes. Working as a contract chemist, I was involved with a stability project to assay a potential drug to be used in the treatment of the Aids virus.

Wisconsin Pharmacal Jackson, Wi. Dec. 1995 - April 1997

Senior Validation/Analytical Chemist.

Initiated and performed all validations to comply with cGLP/cGMP/USP/FDA requirements for all assays and processes including OTC drugs. Assayed all new formulations and raw material to ensure specification/monograph compliances. Maintained various complex stability studies utilizing HPLC and GC instrumentation. Responsible for the cross training and mentoring of associate level chemists, worked in conjunction with the Red Cross to develop, test, and market the female condom. One of several separated from company due to company reorganization.

Abbott Laboratories North Chicago, Ill. March 1995 -Aug. 1995

Contract Research Associate

Performed various assays for stability, potency, and purity of bulk and packaged experimental cancer drug samples utilizing various GC and HPLC equipment under GMP/GLP conditions. Performed method development, validation, and forced degradation studies.

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