Quality Assurance Director
| Category: | Professional |
| Location: | Eugene, OR 97401 |
| Pay: | $125,000.00 Annually |
| Posted: | 3 weeks ago |
| Status: | Open |
Description
Quality Assurance Director
Lead compliance, ensure quality, and shape health innovation at a top nutraceutical manufacturing partner.
What's in it for you?
- Medical, Dental and Vision Insurance
- Two robust EAP programs
- Oregon Saves IRA
- Life Insurance
- Long-term and short-term disability
- Paid holidays, 8 bonus birthday hours
- Sick and personal paid time off
Quality Assurance Director Details:
Direct Hire position- $
125,000.00 / annually First Shift
- Interpret and apply FDA regulations (21 CFR Part 111), FTC guidelines, DSHEA, and other applicable global regulatory requirements. Oversee product label reviews and claims substantiation to ensure compliance with FDA and FTC regulations.
- Serve as the primary liaison with regulatory agencies (FDA, NSF, OTCO, SQF, etc.) and respond to inquiries or inspections.
- Prepare and submit regulatory filings, including New Dietary Ingredient (NDI) notifications and GRAS submissions, as needed.
- Monitor regulatory developments and assess their impact on the company’s products and operations; ensure timely adaptation to changes in regulations.
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with cGMP (21 CFR Part 111) and SQF standards.
- Manage product testing programs, including raw material verification, finished product testing, stability studies, and third-party certifications.
- Investigate non-conformance, deviations, and customer complaints; lead Corrective and Preventive Actions (CAPA) processes.
- Maintain comprehensive quality documentation, including batch records, SOPs, training records, and audit reports.
- Train staff in regulatory and quality procedures, including cGMP compliance and industry’s best practices.
Quality Assurance Director Qualifications:
- Bachelor’s degree (BS) in Regulatory Affairs, Microbiology, Food Science, Nutrition, or a related field is required; advanced degree preferred
- A minimum of ten years of experience in regulatory affairs or compliance within the dietary supplement, food, or pharmaceutical industries.
- Demonstrated knowledge of FDA regulations, DSHEA, GMP, and other relevant compliance standards.
- Strong communication and interpersonal skills, with the ability to collaborate effectively across departments.
- Proficient in Microsoft Office, Word, Excel and SharePoint.
- Ability to understand and learn new ERP programs such as FishBowl.
We are an Equal Opportunity Employer and celebrate diversity at all levels of our organization.
Our commitment to you: to be Kind, Helpful, Respectful, Honest and Committed To Finding You Work.
How to Apply:
Email, call, or text us today! Feel free to apply online at www.elwoodjobs.com!
Oliver Bergen
3025 Washington Blvd.
Ogden, UT 84401
(801) 781-2310 ext.
oliver.bergen@elwoodprofessional.com
Qualifications
*See above for qualifications
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