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Thorne is a health and wellness company delivering science-backed solutions to empower individuals to take a proactive approach to their well-being. The Quality Assurance Specialist II is responsible for quality operations and compliance within a cGMP manufacturing environment, supporting a team of 750+ professionals.
Key responsibilities include managing relationships with contract manufacturers and coordinating communication on requirements and supply chain integrity. The role initiates and completes customer complaint investigations, communicates findings and root causes, and coordinates Corrective and Preventive Action (CAPA) systems. You will participate in Adverse Event board meetings to investigate applicable events and oversee stability programs by reviewing stability data on normal and accelerated studies, informing Quality Management of anomalies.
The specialist maintains thorough knowledge of Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs), proactively identifying and resolving quality problems and process improvement opportunities. Responsibilities include coordinating and participating in internal audits and inspections across departments, overseeing CAPA documentation through EtQ, and conducting Product Quality Reviews (PQR) for designated products. You will conduct mock recall exercises, provide support during regulatory audits, and write or revise SOPs and controlled forms to ensure best practices.
Additional duties include participating on process improvement teams, providing quality review and feedback on new products and processes, and offering ongoing support to employees on quality system requirements. The role requires ensuring compliance with cGMP, FDA, OSHA, and other regulatory requirements, compiling periodic reports for management, and demonstrating initiative in suggesting improvements and discovering innovative solutions.
Required qualifications include a Bachelor's degree with four years of related experience (or equivalent education/experience combination), demonstrated familiarity with standard quality concepts and procedures, and experience in a cGMP manufacturing environment. The candidate must lead and work effectively with cross-functional teams, work independently with minimal direction in a fast-paced environment, and be willing to travel 5-10% as needed.
