Quality Assurance

Gerald (Jerry) Orehostky, PhD
Vice President, Quality and Regulatory

Jerry has more than 30 years of broad experience in Quality Systems, Regulatory Affairs, Regulatory Compliance, QA, Product Development and Commercial Operations in Biologics, Bioconjugation, and other therapeutic areas. His extensive experience and, in-depth functional proficiency in Quality Assurance & Regulatory Affairs from early stage to commercial products will help guide Goodwin as we continue our expansion plans to continue our nearly 30-year legacy of servicing our clients in bringing their products into, and through the clinic with our unmatched service, flexibility, and quality. We are now transcending the clinic and taking the company into commercial manufacturing, and Jerry’s leadership will be instrumental towards this endeavor.

Jerry has held leadership positions within Regulatory Affairs and Quality Operations at companies such as Actinium Pharmaceuticals, Antares Pharma, Discovery Laboratories, Palatin Technologies, Schering-Plough, Vivus, and Interferon Sciences. He maintained a high level of compliance through Product Development and Commercial Operations and was responsible for the generation and submission of applications and registrations for several products that were successful in attaining US, Canadian, and EU marketing authorizations.

Sandra Isaacs, CQA
Senior Manager, QA – Product Release

Sandra has nearly 20 years of experience in developing and optimizing Quality Systems in cGMP environments for manufacturing biopharmaceuticals, pharmaceuticals, medical devices, as well as human cells / tissue and tissue-based products. Prior to joining Goodwin Biotechnology nearly 7 years ago, she managed the QA department at Bio-Tissue Inc. and worked as a Quality Management Systems Specialist at Andrx Pharmaceuticals. Sandra earned her Bachelor of Science degree in Chemistry, Physics, and Biochemistry at the University of the West Indies and has completed post graduate studies to earn a graduate certificate in Total Quality Management from the College of Engineering at the University of South Florida. Sandra has also earned a Certified Quality Auditor certification from the American Society for Quality (ASQ).

It is the policy of Goodwin Biotechnology to use appropriate management systems to carry out our mission. Quality is the intrinsic focus of all management practices that make up these systems. These practices include the following elements: proper planning, performance of appropriate tasks, timely assessment, and continuous improvement of established processes. By addressing these elements in the research, development, operations, and support activities, defined goals are met and both the Goodwin Biotechnology and the client requirements are satisfied. All work is performed with dedication to excellence and with an objective of dynamic and continuous improvement.

Each department at Goodwin Biotechnology involved in GMP manufacturing maintains a quality program that meets its specific needs and is consistent with the guidelines provided in the Goodwin Biotechnology Quality program. Goodwin Biotechnology Quality Assurance continually monitors these programs to assess their effectiveness. Quality Assurance is also responsible for review, approval, and control of critical processing steps, component release, and documentation in support of GMP manufacturing. Our quality systems include:

cGMP Documentation
Audit and Review
Approval and Release
Vendor Audit
cGMP Training
CAPA

Goodwin Biotechnology has established a Drug Master File (DMF) with the FDA.

Quality Assurance maintains programs for vendor qualification, and internal and external audits, as well as procedures for responding to client and regulatory agency audits of Goodwin Biotechnology operations.

For more information on our Quality Assurance services please fill out the form below.

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