Quality Assurance Manager

About Onnit:

Onnit is an Austin, TX-based supplement company dedicated to supporting everyday heroes-those who need to be fully present and at their best, not only for themselves but also for their families, friends, and colleagues. As a trusted, serious supplement brand, we provide high-quality products with clinically studied ingredients designed to unlock a deeper mind-body connection and enhance both mental and physical performance.

Unlike other supplement brands, Onnit enables strength from within, empowering individuals to operate at their peak every day. Backed by medical professionals, industry experts, and a loyal community, we are rapidly growing while staying true to our mission of total human optimization. Recognized as a Best Place to Work in Austin by the Austin Business Journal, we take pride in fostering a dynamic and purpose-driven environment-and we'd love for you to be part of it.

About the Job:

The Quality Assurance Manager is responsible for overseeing and continually enhancing the organization's quality systems, ensuring full compliance with applicable FDA regulations under 21 CFR Parts 111 and 117. This role serves as the primary administrator of the electronic Quality Management System (eQMS) and manages key quality processes including document control, training, change control, CAPA, deviations, and complaint handling. The Quality Assurance Manager is instrumental in upholding product integrity, safeguarding consumer safety, and maintaining regulatory compliance across all operations.

KEY RESPONSIBILITIES:

• Serve as the primary system administrator for the eQMS, managing user roles, permissions, workflows, and system access.
• Manage controlled documents (SOPs, policies, specifications) within the eQMS and oversee document creation, review, approval, version control, and archiving.
• Facilitates and organizes trainings matrix as well as training documents for employees on SOPs, documents, forms and GMPs and ensure company-wide compliance training is up to date.
• Manage product complaints, including Adverse Event (AE) tracking, investigation, and reporting.
• Review and approve COAs (Certificates of Analysis), SOPs, stability reports and other quality documents.
• Log and track non-conformances, deviations, and CAPA activities; monitor progress to ensure timely completion and effectiveness checks, analyze trends, and escalate recurring issues as necessary.
• Conduct internal audits and support third-party, FDA, and regulatory inspections
• Generate and analyze quality KPIs and trends and present quality data for management reviews and continuous improvement initiatives.
• Maintain inspection readiness through accurate and up-to-date quality records
• Oversee quality control and quality assurance processes, including finished product release.
• Collaborate with production, R&D, procurement, and regulatory teams to ensure quality objectives are met.
• Develop and deliver training on eQMS usage, GMP, and quality processes to internal users

Requirements

• Strong understanding of FDA regulations (21 CFR Part 111/117) and GMP requirements
• Proficiency in Microsoft Office; familiarity with data visualization tools a plus
• Experience with eQMS platforms
• HACCP, PCQI certifications (optional, but preferred)
• Experience with FDA inspections

Benefits

• Full medical, dental, and vision benefits
• Basic Life Insurance
• 401(k) eligibility with company matching
• Flexible Vacation and time off policy
• $100/month wellness stipend
• Paid holidays
• Competitive compensation
• Tuition reimbursement
• Fringe benefits including free access to Onnit Academy gym ; co-pay healthy meals; among many others

EOE race/color/religion/sex/sexual orientation/gender identity/national origin/disability/veteran status