Director, Quality Control
- Summerville, SC
Thorne is a personalized health solutions company dedicated to improving individual outcomes through science and technology. For over 30 years, Thorne has led the nutritional supplement industry in providing researched-based, high-quality natural products, including foundational vitamins and minerals, therapeutic-focused nutritional supplements, and NSF Certified for Sport products. By leveraging cutting-edge research and personalized data through affiliate WellnessFX, Thorne offers customized preventive health solutions for practitioners, their patients, and athletes.
The Director, Quality Control (QC) follows established quality control/quality assurance procedures to ensure the correct and prompt test of raw materials, mixtures and finished products of Thorne Research. The Director, Quality Control oversees all activities in the Quality Control laboratories.
· Plan, direct and coordinate the operational activities of the Quality Control lab.
· Identify, develop and validate analytical methods to be performed in-house.
· Assess, acquire and validate necessary equipment.
· Meet company expectations for timeliness of lab studies and product shipments.
· Direct, review, and approve laboratory method validation protocols and laboratory equipment qualifications.
· Ensure test methods and production processes meet specified protocol or SOP requirements, are scientifically sound and are performed error-free.
· Ensure quality systems are being applied in the performance and documentation of lab studies and production processes.
· Assist the QC Laboratory Manager and Operations with the interpretation of test results and to determine additional steps to be taken, as needed.
· Perform a failure investigation identifying root cause and take corrective/preventive action in the event of a failure.
· Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
· Ensure compliance with applicable quality and regulatory requirements (qualified/trained staff, validated equipment, proper documentation practices, etc.).
· Demonstrate awareness of cross-contamination issues while testing materials, and exhibit vigilance in taking proper precautions to maintain a clean and sterile environment.
· Maintain a safe and healthy work environment by establishing and enforcing organizational safety standards and adhering to legal regulations.
· Take initiative and make sound decisions within the guidelines provided, and is willing, if necessary, to stop a procedure or process when SOP or product quality is in question.
· Address observations or recommendations as well as implement corrective/preventive actions as needed.
· Demonstrates knowledge of and teaches department procedures and company polices, pays attention to detail in all aspects of testing, ensuring the completion of all paperwork accurately, neatly and fully.
· Demonstrate initiative and job knowledge by suggesting ideas, discovering new and better ways of accomplishing goals and finds innovative, well thought-out solutions to problems.
· Ability to perform other duties as required.
· Build and lead a highly performing team, secure the best talent, develop and strengthen staff and future leaders, and provide ongoing coaching and feedback.
Experience and/or Education: Advanced degree in Chemistry or a related field preferred plus 10+ years’ experience in laboratory supervision and management, detailed knowledge of USP requirements, minimum 5 years’ experience in an FDA-regulated environment. Experience with ISO and/or GMP standards required.
Language Ability: Employee is able to read and understand at a highly technical and proficient level. The employee follows instructions, both verbal and written, and communicates effectively with supervisors and fellow employees.
Computer and Technical Skills: Employee can use the equipment and software required to accomplish the responsibilities of the position. Ability to perform simple and complex calculations and conversions as related to laboratory equations and requirements.
· Comprehensive understanding of the natural products and pharmaceutical marketplaces.
· Demonstrates ability to develop and deliver upon business objectives.
· Experience with laboratory practices including ICP, FTIR, and GC/MS.
· Knowledge of the scientific method, chemical products, test procedures, and composition of raw materials. Knowledge of chemical terminology and units of measure.
· Demonstrates ability to initiate, perform, and complete studies and reports in a timely manner.
· Ability to work independently with little direction in a fast-paced environment.
· Ability to build, develop, motivate and engage high-performance teams.
· Supervise and manage others, delegate appropriately, and follow-up on work assignments.
· Assess talent, hire new staff, conduct formal and informal performance assessments, and address employee non-performance.
· Develop and deliver on assigned objectives within requested timeframes.
· Work cooperatively with managers in other departments.
THORNE RESEARCH IS AN EQUAL OPPORTUNITY EMPLOYER