Job Description
Regulatory Site Quality Specialist
Location: hybrid (Florham Park, NJ
Type: Contract | Full-Time
Industry: Large Consumer Packaged Goods (CPG) Company
Job Overview
We are seeking a Regulatory Site Quality Specialist to support a leading CPG company’s OTC drug listing portfolio. This role will manage the drug listing process for skincare and cosmetic products, ensuring compliance with FDA regulations and GMP standards. You will collaborate with cross-functional teams to review and approve change requests, deviations, and CAPAs, while providing GMP consultation and supporting regulatory operations.
Key Responsibilities
- Manage OTC drug listing and delisting processes for skincare and cosmetic products.
- Review and approve raw material documentation, LIMS specifications, Certificates of Analysis, GMP batch records, packaging protocols, and clinical labeling records.
- Support analytical documentation including test methods, protocols, and reports.
- Participate in internal audits as a scribe and document reviewer.
- Provide GMP consultation to project teams and departments.
- Serve as backup for QA Manager as needed.
Required Skills & Experience
- BS degree in Science or Engineering.
- 5+ years’ experience in Regulatory, Quality, R&D, or Analytical roles within a GMP facility.
- Strong understanding of FDA OTC Drug Listing Process and GMP procedures.
- Experience with SOPs, deviations, change controls, and CAPAs.
- Detail-oriented and highly organized.
- OTC drug or cosmetics experience.
Nice to Have
- LIMS experience.
- Cosmetics or skincare experience.
Job Tags
Full time, Contract work,