Overview

Job DescriptionJob DescriptionDescriptionAt Thorne, we work to deliver high-quality, science-backed solutions to empower individuals to take a proactive approach to their well-being. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you'll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions at every age and life stage.The Quality Assurance (QA) Specialist II is responsible and accountable for quality tasks and operations. Possesses and applies a broad knowledge of Quality principles, practices, and procedures. Supports Change Control process, Corrective and Preventive Action (CAPA) system, nonconforming material process internal audit process and third-party audit process. Works with the Material Review Board, Purchasing, and internal and external partners to resolve product issues. Must be able to lead and work with cross-functional teams and track projects to completion. Requires experience in a cGMP manufacturing environment plus demonstrated familiarity with standard quality concepts, practices, and procedures. RESPONSIBILITIESManages working relationships with all Thorne Research outside manufacturers. Coordinates with contract manufacturers to ensure adequate communication on and understanding of requirements.Builds strong working relationships with purchasing, engineering, quality, planning, and the sales team when dealing with requirements for contract manufacturing and supply chain integrity.Initiates and completes customer complaint investigations. Communicates complaint investigation details, root cause, and CAPAs (when applicable) to appropriate parties.Oversees the stability program by reviewing stability data on normal and accelerated studies. Informs Quality Management and stakeholders of any anomalies or potential stability issues. Becomes thoroughly knowledgeable of the applicable portions of Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) and maintains knowledge base on an ongoing, timely basis as procedural changes occur without relying on management intervention or direction.Proactively initiates the development of streamlined systems to effectively identify and resolve quality problems and process improvement opportunities.Coordinates and participates in internal audits and inspections of various departments/processes including planning of audits, execution, preparation and communication of audit reports, and follow-up on audit findings.Coordinates CAPA meetings and oversees CAPA documentation through EtQ. Provides support and leads when necessary, root cause analysis, and development of corrective and preventive actions.Conducts raw material evaluations to provide feedback on alignment between supplier's specification and Thorne's specification. Identifies any quality risks and communicates to Purchasing, Medical, and Engineering as necessary.Conducts Product Quality Reviews (PQR) for Australia products and for Thorne core products as directed.Conducts mock recall exercise and provides a final report to Quality management.rovides support during regulatory audits through note taking and serving as a runner to gather required documents. Writes, revises, and reviews SOPs, controlled forms and related documents as needed to ensure best practices and current operations. Reviews and approves documents through the change control process.Demonstrates knowledge of department procedures and company policies, pays attention to detail in all aspects, and completes all paperwork accurately, neatly, and fully.Participates on process improvement teams to provide quality input and direction. Ensures that documentation of improvements is completed and approved as needed.Provides quality review and feedback on new products and processes as required.Provides ongoing support to all employe