Position Summary

The Quality Assurance Specialist ensures compliance with regulatory standards (21 CFR part 111), company policies, and customer expectations in the distribution of branded dietary supplements. This role collaborates with internal teams and co-packers to support quality initiatives and ensure product excellence. Responsibilities include handling customer complaints, managing retailer documentation requests, overseeing finished product approvals, and maintaining quality systems to drive continuous improvement. The Quality Assurance Specialist plays a critical role in safeguarding the integrity, safety, and compliance of the company’s products

Essential Functions

• Maintain and update audit-ready quality documentation, including SOPs and product specifications.
• Approve finished products, ensuring compliance with regulatory and internal standards.
• Manage and submit quality documentation, including Certificates of Analysis (CoAs) and testing results.
• Coordinate annual product testing with third-party labs for accuracy and timeliness.
• Investigate customer complaints, identify root causes, and implement corrective actions.
• Update company policies due to regulatory changes.
• Conduct or coordinate quality training sessions for internal teams and co-packers.
• Analyze quality data trends to drive process improvements.
• Collaborate with co-packers, suppliers, and internal teams to resolve quality issues.
• Enhance quality systems and workflows to improve efficiency and reduce errors.
• Maintain electronic Quality Management System (eQMS) records.

Education and Experience Requirements

• Bachelor’s degree preferred.
• Prior experience in quality assurance with a solid understanding of QA principles and practices.
• Working knowledge of cGMP under 21 CFR Part 111.
• Familiarity with electronic Quality Management Systems (e.g., TrackWise, MasterControl).
• Proficiency in Microsoft Office applications (Word, Excel, Outlook)

Preferred Qualification

• Strong analytical and problem-solving skills.
• Creative and strategic thinking with a desire for continuous learning.
• Excellent verbal and written communication skills.
• Proven ability to prioritize tasks and work effectively in a fast-paced, deadline-driven environment.
• Strong attention to detail and interpersonal skills to collaborate across departments.