Director - medical quality

3 weeks ago


Hayward CA, United States NeoLife Full time

NeoLife is a nutrition company that has been in business for 65 years and operating in over 50 countries around the world. We offer superior quality products using nature's finest whole food ingredients that are based in nature and backed by leading edge science. he Quality Director oversees the operational aspects of the Quality Control and Quality Assurance Department relating to the manufacture, testing, and distribution of products in strict accordance with Standard Operating Procedures, current Good Manufacturing Practices, FDA food and dietary supplement regulations.
Responsible for overseeing the execution of raw material and finished good testing for NeoLife's domestic and international markets.
* Responsible for interpreting the results of all testing and reporting any issues to VP and to the Research & Development team.
* Responsible for overseeing the development of necessary documentation including SOPs, analytical testing documentation, and product dossiers.
* Manage stability studies including creating stability protocols, placing new and reformulated products in stability, and performing technical review of stability test results.
* Responsible for the operation of a Material Board Review for raw material substitutions, shelf-life extensions, and rejections.
* Collaboration with internal personnel and outside consultants to ensure accuracy and compliance of domestic and international labels.
* Bachelor of Science Degree in chemistry, biochemistry, biochemical engineering, life science, or related field. 6-8 years or more of Quality Management experience in a manufacturing environment for Dietary Supplement products.
* Demonstrated abilities to develop and supervise Quality Control and Quality Assurance laboratory personnel.
* Strong Knowledge of Quality Systems Design and Implementation.
* Must have experience with document control systems and processes and product release procedures including testing deviations.
* Experience in working with the Purchasing and R&D teams in the development and implementation of raw material specifications and finished good specifications to safeguard consistent supply chain and to ensure the integrity of the product design.
* Proficiency in Microsoft Office Suite of applications (Word, Excel, Outlook)
All candidates must have legal authorization to work in the United States without visa or employer sponsorship. NeoLife offers a comprehensive benefit program including medical, dental, and vision insurance, 401k retirement plan, health care & dependent care flexible spending accounts, life insurance, and other great benefits Please visit our website at ( to learn more about us


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