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Katy Harton

@katyharton

Product safety and quality manager at Biocodex covering orphan drugs and supplements, with hands-on FDA submissions and label review experience.

United States

Message

At Biocodex, I provide North American quality and regulatory coverage for orphan drugs and dietary supplements. I coordinate FDA facility registration and Prior Notice submissions, and prepare Supplement Facts panels while verifying ingredients during label review.

I administer the electronic QMS and manage SOPs, document control, and training tracking. I also coordinate promotional reviews through Veeva and oversee supplier audits, deviations, CAPAs, and change controls.

Earlier at Alphanumeric, supporting Janssen Pharmaceuticals, I worked across quality supervision, quality analysis, and medical information. I prepared quality metrics, reviewed adverse event and product quality complaint reports, and handled medical information requests from healthcare professionals and consumers.

Experience

Work history, roles, and key accomplishments

Current

Manager, Product Safety & Quality Assurance

Current

Biocodex

Jul 2024 - Present (2 years 4 months)

Manages product safety and quality assurance for North America, overseeing FDA facility registration, Prior Notice submissions, label review, and QMS administration. Leads cross-functional compliance, audits, and CAPA activities.

QMS Document Control CAPA Deviation Management Root Cause Analysis FDA Regulations 21 CFR Part 111 Health Canada Regulations Supplier Audits Promotional Review Veeva Safety Data Sheets

Quality Supervisor

Alphanumeric

Mar 2023 - May 2024 (1 year 2 months)

Supervised quality operations for Janssen Pharmaceuticals, preparing quality metrics, managing deviations and nonconformances, and developing SOPs and training materials.

Quality Metrics Excel Quality monitoring Root Cause Analysis CAPA SOP Development Training Mentorship

Quality Analyst

Alphanumeric

Apr 2021 - Mar 2023 (1 year 11 months)

Reviewed calls, adverse event reports, and product quality complaints for compliance, identified noncompliance, and trained staff to improve quality standards.

Adverse Event Reporting Product Quality Complaints Management Compliance Training Quality Metrics Non Conformance Management

Medical Information Specialist

Alphanumeric

Feb 2020 - Apr 2021 (1 year 2 months)

Handled inquiries from healthcare professionals and consumers regarding adverse events, product quality complaints, and medical information requests, consistently meeting key performance indicators.

Medical Information Adverse Event Reporting Product Quality Complaints Management Customer Service KPIs