An easier day. A healthier life. A better way.
As innovators of modern living, that's our promise to our customers.
We are an exciting, fast paced, multi-channel consumer products company that offers competitive salaries and benefits in a collaborative, progressive and team-oriented environment. We look forward to having you join our team!
Current opportunities available:
The Ideal Living Team!
Job Title: Senior Quality Assurance Specialist/Engineer
Therabotanics is a rapidly growing health and wellness company engaged in the marketing, sales, and distribution of premium natural health-related products and supplements through all forms of media. We are committed to the physical and emotional wellbeing of our consumers and fully dedicated to extraordinary service for our customers.
The Senior Quality Assurance Specialist/Engineer will be responsible for the management of the Company's product quality program to ensure that all Company products meet the Company's product specifications, cost and service objectives and overall product quality standards. Reporting to the Vice President of Quality, this role will also develop and maintain a quality program and oversee the all quality protocols to ensure compliance with applicable laws, regulations and Standard Operating Procedures.
- Build and maintain a collaborative relationship with the senior leadership teams and vendors to support and aid in the implementation of all quality programs
- Report to management on quality issues, trends and losses
- Create and maintain Standard Operation Procedures (SOPs) for all quality control and assurance, management of customer complaints, adverse events and product safety
- Prepare required regulatory submissions, including FDA MedWatch reports
- Liaise with external audit agencies and consultants to resolve observation audit issues and/or communicate compliance information
- Provide technical assistance for new products, packaging and processes
- Troubleshoot quality related issues as necessary or requested
- Maintain proper record keeping to ensure compliance with Good Manufacturing Practices, FDA regulations and SOPs
- Communicate and train quality and product safety guidelines to call center staff
- Evaluate complaints for medical significance and determine if complaints meet reporting requirements for an adverse event in consultation with product specialists as needed; determine corrective action and manage accordingly with proper documentation
- Review, approve and release/reject raw materials and finished products with proper documentation
- Develop and manage quality test plan methods for all product lines
- Set up third party COA specification and stability testing for all product lines
- Monitor vendor performance and establish criteria and rating systems
- Review purchase orders, contracts and change requests and ensure that the necessary criteria and provisions are included in product specifications and meet label and other marketing claims
- Interact with factory to identify opportunities to improve quality and lower product costs
- Perform routine internal cGMP audits
- Train employees as to the FDA cGMP requirements relating to dietary supplements
- Conduct external supplier qualification compliance audits, report corrective action (if any) and maintain proper records
- Manage FDA compliance for the manufacturing, holding, shipping, customer service, and returns for dietary supplements
- Create and analyze various call center related reports that is utilized by senior management
- Other duties as assigned
Minimum Education and Experience
- 2+ years of work experience in Quality Assurance or Quality Control, GMP's, Food Safety and regulatory compliance within the food or dietary supplement industry is required
- Bachelor's or Master's Degree in biology, microbiology, food science, chemistry, pharmacy or related field is preferred
- Strong computer skills, including Microsoft business applications and various reporting software
- Must have strong project management, business writing, and reporting skills
- Experience in a manufacturing facility with fundamental knowledge of Quality Assurance or Quality Control is highly preferred
Knowledge, Skills, and Abilities
- Excellent written and verbal communication skills
- Ability to read, analyze, and interpret common information, reports, and other documents
- Understand state and federal requirements for manufacturing, distribution, marketing, and sale of dietary supplements
- Solid knowledge of Good Manufacturing Practices for the care, handling and storage of products
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, and/or company representatives
- Ability to effectively present information to management and work cross-functionally across all levels of the organization and with external manufacturing and distribution partners
- Ability to work regular full-time work schedule, with flexibility to work additional hours to meet business needs
- Ability to perform multiple tasks simultaneously, keep accurate records
- Good organizational skills with strong attention to detail
- Good work ethic with high work standards
- Strong teamwork and interpersonal skills to work with a very interactive and self-directed work team
What We Provide
We offer competitive compensation and benefits, including, health, dental and vision plans, employer paid life insurance, paid holidays and paid time off, and a 401k plan.