What are the responsibilities and job description for the Quality Specialist position at Onnit?
About Onnit:
Onnit is an Austin, TX-based health and wellness brand focused on encouraging a peak level of human performance through the best in nutritional supplementation, health-conscious foods, and unconventional fitness equipment and training. We are rapidly growing through support from professional athletes, medical practitioners, and our thousands of customers. We are proud of our Austin roots and have established a world-class gym next door to our headquarters. We’re excited to be named a Best Place to Work in Austin by Austin Business Journal, and we’d love to show you why.
About the Position:
Want to be a part of Onnit's Total Quality Optimization? The Quality Department at Onnit is responsible for managing everything related to the integrity of the products we sell. In addition to being resourceful and proactive, Quality department employees are expected to be efficient with their time, organized, and good communicators to ensure timely, quality execution of the vision.
Responsibilities:
- QMS system knowledge – knows the basic and more in-depth functions of QMS systems including complaint management, CAPAs, Non-Conformances and Auditing
- Manages sign-offs and investigations for adverse events
- Asana proficiency – understands and manages tasks, projects and pipelines in Asana
- Helps trend and present Adverse event data
- Monitor and File Serious Adverse Events
- Requests and manages upkeep of Supplier documentation
- Coordinates external audits and 3PL audits
- Tracks and manages 3rd party certification testing
- Coordinates internal warehouse and internal audit schedule for processes and procedures
- Assist with Third Party Audits (NSF, FDA, and TXDH)
- Maintains Training matrix and training documents
- Facilitates and organizes trainings for employees on SOPs, documents, forms and GMPs.
- Master of document control – funnels changes through the change control pipeline for Quality team review
- Maintain knowledge of GMPs and GDPs
- Knowledge and familiarity of 21 CFR Part 111 and 117
Requirements
Minimum Requirements
- College Degree
- Knowledge and familiarity of 21 CFR Part 111 and 117
- 3-6 Years of Food or Supplement Quality Experience
- If you are a qualified candidate interested in applying, please provide a resume and cover letter describing your previous experience and goals. A cover letter is required to be considered for this position.
Benefits
- Full medical, dental, and vision benefits
- Basic Life Insurance
- 401(k) eligibility with company matching
- Flexible Vacation and time off policy
- Paid holidays
- Competitive compensation
- Tuition reimbursement
- Fringe benefits including free access to Onnit Academy gym and Black Swan Yoga studios; co-pay meals among many others
EOE race/color/religion/sex/sexual orientation/gender identity/national origin/disability/veteran status