Quality Specialist

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 Specialist is an essential member of the Quality Assurance team, responsible for maintaining the highest quality standards throughout the testing, release, and distribution of dietary supplements. This role requires a deep understanding and competency in 21 CFR Part 111 and 117. Key responsibilities include overseeing document control, managing change processes, facilitating training, product release and tracking and trending adverse events to ensure compliance and product safety. 

KEY RESPONSIBILITIES:

• QMS System Knowledge: Demonstrates proficiency in the basic and advanced functions of the QMS systems, including document management, complaint management, CAPAs, Non-Conformances, Training and Complaints.  
• Adverse Event Management: Manages sign-offs and investigations for adverse events, trending data, and handling Serious Adverse Events. 
• Data Trend Analysis: Helps track, analyze, and present adverse event data to support decision-making and quality improvements. 
• Third-Party Certification Testing: Tracks and manages testing processes for third-party certifications, ensuring timely and accurate reporting. 
• Training Management: Maintains the training matrix and training documents, ensuring all employees are trained on SOPs, documents, forms, and GMPs. 
• Training Facilitation: Coordinates and facilitates training sessions for employees, ensuring compliance with company policies and industry regulations. 
• Document Control Mastery: Manages document control by ensuring changes are funneled through the change control pipeline for thorough review by the Quality team. 
• Change Control Processes: Manages and monitors the change control process to ensure all modifications to products, processes, or documentation are reviewed, approved, and documented in compliance with regulatory and internal quality standards. 
• Assists with product release as needed 
• Perform internal audits for regulatory or supplier quality management. 
• Review and development of SOP’s and Forms 
• Assist with collecting lab quotes and product testing 
• Support stability program  
• Support Regulatory Document Control  

• A minimum of 3 years industry QA/QC experience in cGMP environment
• A degree in a scientific discipline (Chemistry, Engineering, Physics, Biology), preferred
• A robust knowledge of good documentation practices (GDP)
• Knowledge of 21 CFR Part 111 and 21 CFR Part 117
• Strong familiarity with Microsoft suites
• Experience with Quality Management Systems preferred
• Excellent written and verbal communication skills
• Superior attention to detail and organizational skills
• Ability to work effectively with people and communicate information to obtain positive results
• Comfortable working independently and able to manage time efficiently and adjust to shifting priorities quickly
• Ability to work well under tight deadlines
• Strong communications (both orally and written) and mathematical skills.
• Must have excellent attention to detail and have the ability to multi-task and prioritize.

• 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