| Qualifications:
- Bachelor’s degree in Life Sciences, Chemistry, Biology, Food Science, or a related field (or equivalent combination of education and experience).
- 1–3 years of experience in QA or regulatory affairs in the nutraceutical, pharmaceutical, or food industry.
- Working knowledge of cGMPs (21 CFR Part 111), FDA/Health Canada labeling regulations, and relevant quality systems.
- Strong attention to detail, organizational, and communication skills.
- Proficiency with Microsoft Office (Excel, Word, Outlook).
- Ability to manage multiple tasks while maintaining documentation accuracy.
Preferred Qualifications:
- Experience with e-document systems or ERP platforms.
- Familiarity with dietary supplement claims and marketing regulations.
- Knowledge of international regulations (e.g., EU, TGA, etc.) is a plus.
- Label compliance review experience (FDA DSHEA, NPN/NNHPD in Canada).
Physical Requirements:
- Ability to occasionally lift up to 25 lbs.
- Comfortable working in both office and production environments.
- Occasional standing or walking in a manufacturing or warehouse setting.
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| Location: Miramar
Salary: $20-$23 per hour
Employment Type: Full-Time
Position Summary:
The QA/Regulatory Technician plays a critical role in supporting quality assurance and regulatory compliance functions within a nutraceutical manufacturing facility. This position ensures that all products meet applicable regulatory requirements (FDA, Health Canada, cGMP) and internal quality standards by assisting with documentation, audits, product labeling, and ingredient verification.
Key Responsibilities:
Quality Assurance Duties:
- Review batch production records (BPRs) for completeness, accuracy, and compliance with GMP requirements.
- Conduct in-process checks and line clearance verifications to ensure manufacturing compliance.
- Assist with deviation reports, non-conformances, and corrective/preventive action (CAPA) investigations.
- Maintain and update SOPs, quality manuals, and training records.
- Perform document control tasks including the issuance, tracking, and archiving of QA documents.
- Support internal audits and assist in preparing for external audits (FDA, NSF, Health Canada, etc.).
- Collect and organize samples for quality testing and retain programs.
Regulatory Affairs Duties:
- Assist in preparing and reviewing product labels, ingredient declarations, and Supplement Facts/Panel information to ensure compliance with FDA, Health Canada (NNHPD), and international regulations.
- Maintain regulatory documentation such as ingredient specs, Certificates of Analysis (COAs), MSDS, and technical dossiers.
- Support registration or notification of new products to regulatory bodies as required.
- Monitor changes in nutraceutical regulations and notify management of relevant updates.
- Ensure compliance with claims regulations (structure/function claims, health claims, etc.).
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