Quality Specialist
Quality Specialist
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Job Description
About Onnit:
Onnit is an Austin TX-based supplement company dedicated to supporting everyday heroesthose 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 environmentand wed love for you to be part of it.
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 change control complaint management tracking and trending adverse events and NCR/CAPA investigations to ensure compliance and product safety.
PRIMARY DUTIES AND 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.
SUPPLEMENTAL DUTIES AND RESPONSIBILITIES
- Assists with product release as needed
- Perform internal audits for regulatory or supplier quality management.
- Review and development of SOPs and Forms
- Assist with collecting lab quotes and product testing
- Support stability program
- Support Regulatory Document Control
SKILLS CERTIFICATIONS/LICENSES SPECIAL REQUIREMENTS
- Dietary supplement and food knowledge
- Warehouse and manufacturing operations knowledge
- Veeva QMS training and management
- Excel Word PowerPoint
- PCQI
- 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
Required Experience:
Unclear Seniority
Employment Type
Full-Time
