Quality Assurance Specialist Ii

At Thorne we make products that matter - ones that make people's lives better. 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.

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, supplier qualification process, internal audit process and third-party audit process. Schedules, coordinates, and conducts audits of suppliers including, but not limited to, contract manufacturers and raw material suppliers.

Works with the Material Review Board, Purchasing, and Suppliers to resolve product issues. Coordinates and manages relationships with outside contract manufacturers. 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.

FLSA STATUS
: EXEMPT employee.

• Manages 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.
• Coordinates and performs auditing of suppliers. Includes onsite audits of contract manufacturers and other key suppliers.
• Manages supplier qualification process ensuring procedures are executed accordingly and all suppliers are approved prior to purchasing from them.
• Coordinates and resolves supplier quality issues. Includes investigation, resolution, follow-up, and corrective actions.
• Coordinates and maintains supplier quality agreements.
• In conjunction with procurement, maintains approved supplier listing.
• Responsible for approval and disapproval of suppliers.
• Initiates and completes customer complaint investigations. Communicates complaint investigation details, root cause, and CAPAs (when applicable) to appropriate parties.
• Participates in Adverse Event board meetings to coordinate investigation of Adverse Events when applicable.
• 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.
• Provides support during regulatory audits through note taking and serving as a runner to gather required documents.…