Eugene Rynkowski, M.S.
Analytical Chemistry Specialist
Eugene Rynkowski, M.S. - Analytical Chemistry Specialist
Qualifications
Over thirty years experience in analytical development, laboratory management and document control functions. Strong emphasis on compliance for laboratory operations.chemicals and quality assurance responsibilities for drug products, biologics, and bulk pharmaceutical products.
Work History
| 2000 - Present | Senior Consultant | D.H. Gold Associates, Inc. |
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Advise firms on laboratory management, records preparation and retention, laboratory control procedures, calibrations, master test records and analytical validation programs. Prepare and file DMFs and annual DMF updates. Prepare and assist firms for laboratory inspections. |
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| 1994 - 2000 | Independent Consultant | ||
Managed projects for a number of pharmaceutical client firms in the areas of annual product reviews, equipment cleaning, validation, packaging specifications and standard operating procedures. Prepare firms for and assist in regulatory inspections. |
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| 1978 - 1994 | Supervisor and Manager, Quality Control |
Lederle Laboratories |
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Managed the release testing for human and veterinary active pharmaceutical ingredients. Managed regulatory compliance programs for stability, data retention, instrument calibration, reference standards, etc. Organized for and led biannual FDA laboratory inspections. |
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| 1969 - 1978 | Chemist, Analytical Development | Pennwalt Corporation |
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| Development of analytical methods for raw materials and dosage forms. Restructured the product stability program. | |||
Education
| 1977 | M.S. in Mathematical and Applied Statistics | Rochester Institute of Technology | |
| 1969 | B.S. in Chemistry | Rochester Institute of Technology |
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