Open to opportunities

mark wynne

@markwynne

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GMP/GCP-compliant Quality Assurance professional with 4+ years of experience.

United States

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What I'm looking for

I am looking for a remote position in QA within the pharmaceutical or biotech industry, where I can apply my expertise in regulatory compliance and quality systems to drive excellence.

I am a GMP/GCP-compliant Quality Assurance professional with over four years of experience in QA oversight, product testing, documentation control, and regulatory compliance within clinical and manufacturing environments. My expertise lies in batch record review, audit readiness, deviation investigations, and continuous improvement within cGMP systems. I am GCP-certified and have a proven track record of collaborating with cross-functional teams to support FDA-compliant quality systems.

Currently, I serve as a Quality Scientist at Unilever, where I conduct over 50 product quality audits weekly to ensure alignment with GMP and FDA expectations. My role involves performing QA oversight across production and lab workflows, reviewing and maintaining controlled documents, and coordinating investigations for non-conformances. I am passionate about contributing to QA excellence in a remote pharmaceutical or biotech setting, leveraging my skills to enhance product safety and system improvements.

Experience

Work history, roles, and key accomplishments

Current

Quality Scientist

Current

Unilever

Nov 2022 - Present (2 years 7 months)

Conducted weekly product quality audits to ensure GMP and FDA compliance, providing QA oversight across production and lab workflows. Reviewed and maintained controlled documents, SOPs, and batch records, coordinating non-conformance investigations and supporting CAPA. Collaborated with multi-disciplinary teams to enhance audit readiness and quality system improvements.

FDA Compliance SOP Development CAPA

Lab Technologist

LabCorp

Feb 2021 - Oct 2022 (1 year 8 months)

Executed regulated testing of clinical samples under strict chain-of-custody and GLP conditions, maintaining laboratory equipment and performing calibration to minimize data integrity risks. Trained new staff on SOPs and accurate documentation practices. Supported QA documentation through standardized reagent preparation and data QC reviews.

GLP Data Integrity Equipment Calibration

Education

Degrees, certifications, and relevant coursework

Fayetteville Technical Community College

Associate of Science, Biology

Completed foundational coursework in biology, covering essential scientific principles and laboratory techniques. Prepared for transfer to a four-year institution for further studies in biological sciences.

University of North Carolina at Pembroke

Bachelor of Science, General Biology

Studied core concepts in general biology, including genetics, ecology, and cellular biology. Developed analytical and research skills through coursework and laboratory experiences.