Fred Jenkins Email and Phone Number

Developing cGMP (ICH Q7) quality systems for a producer of animal-derived APIs and dietary supplements which includes procedures and programs for laboratory equipment qualifications, analytical method validation, material specifications, impurity profiles, OOS investigations, CAPA, calibrations, stability testing, environmental monitoring, temperature mapping, risk assessments, inspection and testing of intermediates and APIs, data integrity, and supplier audits. Management of quality control laboratory resources and personnel. Development of in-house analytical procedures from USP monograph and general chapter methods.

Please also see the "Accomplishments" section below. Directed the QC/ Technical Services department in all aspects of quality management including supplier qualification, specification planning, conformance to specifications, material disposition, complaint management, non-conformance investigations and corrective actions, documentation management, management of change, equipment qualifications, method validations, cleaning validation, external testing, risk assessments, remote temperature monitoring, calibrations, API stability testing, pest control, mock recalls, and quality/ food safety audits. Scope included evaluations and usage decisions for 450+ raw materials, intermediates, and finished products from multiple manufacturing sites. Promoted and initiated numerous cost saving opportunities in the areas of laboratory equipment and reduced analytical testing. Mentored, directed, and trained employees. Conducted laboratory technical training, annual performance reviews, and created employee development plans.

Led laboratory personnel in all aspects of chemical analysis, specification conformance, procedure development, and required documentation regarding raw materials, intermediates, and finished products.

Developed and implemented chemical process improvements (yield increases, cycle time optimization, waste reduction, raw material sourcing) for the manufacture of various flavoring and fragrance chemicals, and UV filters.

Please also see the "Accomplishments/ Organizations" section below. Developed and implemented chemical process improvements through pilot plant scale up, and product/ applications development of functionalized colorants used in specialty inks. Developed a specialty colorant for inks that would not absorb into PVC substrates.