Microbiologist and Product Quality Assurance Expert Consultant Resume
Resume of JHH Consultant

  • Biotechnology
  • Chemistry
  • Health & Beauty Aids Products
  • Medical Devices
  • Pharmaceuticals

This expert has a M.B.A. from the University of Mary in Bismarck, ND.

While attending the North Dakota State University in Fargo, N.D., this expert received a B.S.

This expert has an A.S. in Computer Science from the Olivet Nazarene University in Kankakee, IL.

This expert is working toward an M.S. in Bioscience Management from George Mason University in Arlington, VA.

Microbiologist and Product Quality Assurance Expert Consultant Resume

This expert specializes in management of product quality systems, training and implementation of GLP, cGMP, GCP, and other FDA guidances (including 21 CFR Parts 11, 820, & ICH Q7A). Further expertise includes documentation and lab facility review, FDA submissions and responses, analytical / method development, chemistry, molecular biology, microbiology, and clinical research.

This expert is highly experienced in areas including supervising, training, hiring, and quality control operations supervision. Further experience includes quality control lab setup, software development, quality systems, safety, assay development and qualification.

Additional experience and specialization includes information systems, regulatory affairs, development of IQ, OQ, and PQ protocols for qualification and / or validation of analytical instruments. This expert has twenty years experience with computers using various operating systems (Windows, Macintosh, Linux) and MS Office and graphic design software as well as programming in Fortran, Pascal, Cobol and Visual BASIC. This expert is also fully trained and certified in validation of computer systems and software validation as per 21 CFR Part 11.

Consultant, Kevin Kennedy Associates Inc.

Providing project management, bioscience management, microbiology, biotechnology, product quality systems management, GLP, cGMP, GCP, and FDA regulatory consulting and related expertise for a wide variety of clients.


Senior Manager of Product Quality Systems, Hematech, Inc., Sioux Falls, SD

Supervision of daily quality control operations throughout company. Managed development of specialized software database exclusive to Hematech. Responsible for federal regulations training and implementation. Designed setup of the quality control lab. Responsible for quality assurance of all documents and processes. Developed and qualified assays (ELISA, RT-PCR, SEC, Western blots, etc.). Member of the following committees: Software development (Chairman), Quality Systems, Safety, Assay Development, Institutional Review Board, and Regulatory Affairs. Assisted in all aspects of Information Systems.


Analytical Science Consultant, Quintiles Consulting, Mundelein, IL

Provided techniques for improving analytical methods and / or validations for products and systems using FDA, GMP and GLP industry guidances. Trained scientists in more efficient and cost saving method development and analytical skills. Composed protocols, Master Validation Plans, test scripts, work instructions, and SOP documents for clients. Recommended new equipment and/or more advanced technologies to improve work flow. Projects included Pfizer, Kalamazoo, MI Implemented 21 CFR Part 11 with both the Computer Compliance and Quality Control / Assurance divisions. Developed IQ, OQ, and PQ protocols for qualification and/or validation of many analytical instruments (including Bran+Luebbe TRAACS, Malvern Mastersizer 2000, Thermo Spectronic Unicam UV, and Bruker-AXS XRD systems among others), computer systems, and software packages. Oversaw senior level managers and QC professionals to assure proper operation of instruments and proper security and flow of data. OraSure Technologies, Beaverton, OR Utilized molecular biological techniques (Western Blots, protein purifications, ELISAs, and Spectrophotometer methods). Implemented cost-effective analytical methods to increase productivity. Organized cross-departmental team meetings for brainstorming sessions on increasing productivity & lowering costs.


Analytical Scientist/ Methods Development Chemist, Pracs Institute, Ltd., Fargo, ND

Served as Team Leader of Gas Chromatography team. Reviewed and performed QA and QC on paperwork and other documentation produced by other analysts. Comprehensively trained in FDA, GLP, GCP and GMP guidelines. Served as Chairman of Analytical Safety team, dealing with all safety issues and concerns within the lab. Developed and validated analytical methods used for the analysis of various biological and pharmaceutical compounds; in total, developed and validated 56 different methods. Developed the above mentioned analytical methods using HPLC w/ UV, FLD, and ECD detection, LC-MS, LC-MS-MS, GC-MS and CE. Performed techniques including solid-phase extraction, organic synthesis, derivitization reactions and sample purification techniques, and trained other employees in same. Wrote analytical procedures, protocols and SOP documents for tasks performed within the lab. Repaired (and in some cases rebuilt) and performed metrology on HPLC, GC-MS and LC-MS-MS systems. Worked with Clinical Research department on setup and performance of projects related to both clinical and analytical work. Served on the Clinical Research Quality Management team. Assisted in the planning and purchasing of equipment and supplies. Performed Software and computer validations on new systems received in the lab. Interacted with clients for various projects and represented the company at national conferences within the biological and pharmaceutical fields.


Research Assistant, USDA Northern Crops Institute, Fargo, ND

Inserted genetically engineered DNA sequences into sunflower cells to produce enzymes for a natural biocontrol mechanism. Performed experiments using Western, Southern, & Northern blots, gel electrophoresis, SDS-PAGE gels, DNA sequencing, PCR, ELISA, RIA, microbiological techniques, spectrometry and fluorometry. Prepped and purified plasmids using purified bacterial and yeast cultures. Screened cDNA libraries, purified protein extracts, and performed cell and tissue culture of sunflowers. Certified in radioisotope handling.


Research Assistant, NDSU Entomology Department, Fargo, ND

Performed experiments in the lab and out in the field on the natural biocontrol of grasshoppers. Set up experiments, raised the specimens, collected and analyzed data and wrote up documents detailing the results. Applied some of this research toward senior biotechnology project at North Dakota State University.


Lab Technician, USDA Bioscience Lab, Fargo, ND

Collected and raised various species of flies for work leading toward the biocontrol of screwworm infestations. Dissected and analyzed the flies to look for specific traits. Sorted out flies by sex and genetic differences. Cross-bred various strains to help enhance various genetic traits.

Eight years experience in supervising, training, and/or hiring employees and keeping documented accounts of their training.

Over eight years in quality service work including training and implementation of GLP, cGMP, GCP, and other FDA Guidances (including 21 CFR Parts 11, 820, and ICH Q7A); performed reviews of documentation and lab facilities; organized FDA submissions and responses.

Twelve years experience in fields of analytical /method development chemistry, molecular biology, microbiology, and clinical research.

Twenty years experience with computers using various operating systems (Windows, Macintosh, Linux); MS Office and graphic design software packages; programming in Fortran, Pascal, Cobol and Visual BASIC; fully trained and certified in validation of computer systems and software validation as per 21 CFR Part 11.

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Peter Habicht, Lead Consultant
Peter specializes in welding and metallurgical engineer with 40 years industry experience in commercial nuclear power plant construction.


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