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Ginger Smith

@gingersmith

I build audit-ready quality systems for FDA, EPA, food, biotechnology, and medical device operations.

United States
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What I'm looking for

I'm looking to lead quality, regulatory, and safety systems in a regulated environment, improving eQMS processes, audit readiness, CAPA, and cross-functional compliance.

I've led quality, regulatory, and eQMS programs across food manufacturing, biotechnology, medical devices, and pharmaceutical operations. At T&T Scientific Corp., I directed QA/eQMS, served as the primary FDA audit contact, and led CAPA, change control, audit readiness, and cleanroom implementation.

At EDP Biotech, I managed FDA clinical-trial timelines and medical device testing while overseeing vendor compliance and laboratory procurement. At Ionogen LLC, I led product development and regulatory testing, coordinated List N Disinfectant EPA registration contract testing, created Safety Data Sheets, and directed industrial hygiene studies.

I'm currently managing laboratory quality operations in food manufacturing, strengthening USDA and SQF compliance, administering OSHA training, and moving paper-based quality documentation into eQMS.

Experience

Work history, roles, and key accomplishments

Education

Degrees, certifications, and relevant coursework

Ginger hasn't added their education

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Tech stack

Software and tools used professionally

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