The Job:
The Quality Assurance Specialist ensures that all manufacturing, testing, documentation, and operational processes comply with cGMP, FDA 21 CFR Part 111, internal quality standards, and customer requirements. This role is responsible for developing and maintaining quality systems, managing change control and deviations, supporting batch release, and ensuring the accuracy and integrity of product and process documentation.
Responsibilities:
- Create, revise, and maintain MMRs, MBRs, specification sheets, COA templates, and other controlled documents
- Ensure all procedures comply with cGMP, regulatory, and company standards
- Initiate, assess, and manage change control requests impacting formulations, suppliers, equipment, processes, or documents
- Ensure timely closure and proper documentation of all quality events
- Review QC lab results, data sheets, and testing documentation for completeness and accuracy.
- Support ingredient and finished-product sampling as needed
- Review batch records for accuracy, completeness, and compliance with the “right-first-time” standard
- Ensuring all production and warehouse personnel are in compliance with cGMPs
- Conducting visual inspections on processes and products on the production floor
- Conduct production line clearances for start-up, cleaning verification, and changeover.
- Conducting product inspections and ensuring all finished goods meet company quality and industry standards
- Recommending corrective actions for potential problems
- Verifying that all equipment are calibrated
- Ensure all products meant for disposal are isolated and dispositioned correctly
- Conduct periodic audits, including glass and brittle material, and equipment inspection to ensure compliance
- Collaborate closely with production, QC, R&D, procurement, and warehouse teams to resolve quality issues
- Any other duties/tasks assigned by Management
- Bachelor’s degree in Life Sciences, Chemistry, Biology, Food Science, or related field (or equivalent experience)
- One to five years or more in Quality Assurance within dietary supplements, nutraceuticals, food, or pharmaceutical manufacturing
- Strong knowledge of cGMP, FDA 21 CFR Part 111, HACCP, and quality systems
- Experience with deviation/CAPA, document control, and change management
- Good written and verbal communication skills
- Basic computer and mathematical skills
- Excellent problem-solving skills
- Detail-oriented with excellent documentation and analytical skills
- Ability to work cross-functionally and communicate clearly
- Good understanding of company standards and expectations
- Actively embraces healthy living
- PTO (Paid Time Off)
- 9% 401k Match
- Company paid Medical, Life, Dental insurance
- Wellness Credit
- Employee Store Credit
- Annual Bonus
- Company Sponsored Events
