Nacar is looking for a Quality Specialist to ensure our quality program aligns with FDA regulations and internal standards. You'll work across departments and with external partners to support the development, commercialization, and ongoing compliance of safe, effective, and high-quality supplements.
What You'll Do
- Review Batch Records and Certificates of Analysis (COAs) for compliance and accuracy.
- Manage Retain Sample Reviews and oversee Product Release.
- Conduct Master Manufacturing Record (MMR) and Product Manufacturing Record (PMR) reviews.
- Manage Change Requests and document their implementation.
- Investigate and track Customer Escalations and Adverse Events.
- Submit Serious Adverse Events (SAEs) via the Safety Reporting Portal.
- Update Finished Product specification sheets.
- Coordinate with Contract Manufacturers on batch issues and sample testing.
What We're Looking For
- Bachelor’s degree in Biology, Chemistry, Food Science, Nutrition, or a related field.
- 1–3 years’ experience in a Quality role within cGMP or other regulated environments.
- Hands-on quality support experience in cGMP manufacturing environments.
- Familiarity with FDA regulations including 21 CFR parts 101, 111, and 117.
- Knowledge of Good Documentation Practices and Document/Records Control.
- Ability to interpret scientific and technical documents.
- Investigative skills related to quality complaints and adverse events.
- Understanding of label claims and formula input calculations.
- Proficiency in MS Office, databases, and project management tools.
Nice to Have
- Experience in the dietary supplements industry.
- Certifications like PCQI, HACCP, or Quality Auditor.
Technical Stack
- MS Office
- Databases
- Project management tools
Work Mode
This position is a hybrid role based in Colorado.
Nacar is an equal opportunity employer.
