Thorne

Purity-focused nutritional supplements with scientific rigor

Quality Assurance Specialist 2

Validation, Compliance & Quality SystemsUpdated on Nov 13

Full-timeSummerville, SC, USANo salary listed

About the Job

Requirements

Requires experience in a current Good Manufacturing Practice (cGMP) manufacturing environment and demonstrated familiarity with standard quality concepts, practices, and procedures.
Requires a bachelor's degree with four years of related experience, or an equivalent combination of education and experience.
Must be able to effect change constructively and provide sound technical and supplier-requirement justifications.
Must work independently with little direction or oversight in a fast-paced environment.
Must schedule projects and meet tight deadlines.
Must be able to travel 5–10%.

Responsibilities

Support the Change Control process, Corrective and Preventive Action (CAPA) system, nonconforming material process, internal audit process, and third-party audit process.
Work with the Material Review Board, Purchasing, and internal and external partners to resolve product issues; lead cross-functional teams and track projects to completion.
Manage working relationships with outside manufacturers and coordinate with contract manufacturers to ensure clear communication and understanding of requirements.
Build working relationships with Purchasing, Engineering, Quality, Planning, and Sales concerning contract manufacturing requirements and supply chain integrity.
Initiate and complete customer complaint investigations, and communicate investigation details, root causes, and applicable CAPAs to relevant parties.
Oversee the stability program by reviewing data from normal and accelerated studies and informing Quality Management and stakeholders of anomalies or potential stability issues.
Maintain thorough knowledge of applicable Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs), keeping current as procedures change.
Develop streamlined systems to identify and resolve quality problems and process-improvement opportunities.
Coordinate and participate in internal audits and inspections, including audit planning, execution, report preparation and communication, and follow-up on findings.
Coordinate CAPA meetings and oversee CAPA documentation in EtQ; support and, when necessary, lead root-cause analysis and development of corrective and preventive actions.
Evaluate raw materials against supplier and company specifications, identify quality risks, and communicate them to Purchasing, Medical, and Engineering as needed.
Conduct Product Quality Reviews (PQRs) for Australia products and designated core products.
Conduct mock recall exercises and provide final reports to Quality Management.
Support regulatory audits by taking notes and gathering required documents; write, revise, and review SOPs, controlled forms, and related documents; review and approve documents through change control.
Complete paperwork accurately, neatly, and fully, and follow department procedures and company policies.
Participate on process-improvement teams, provide quality input and direction, and ensure improvement documentation is completed and approved as needed.
Provide quality review and feedback on new products and processes as required.
Provide ongoing support to employees on quality-system requirements and problem solving.
Compile and create periodic management reports.
Ensure compliance with cGMP, FDA, OSHA, and other regulatory requirements in accordance with company policy.
Adhere to company safety requirements.
Suggest improvements and make sound decisions within established guidelines, including stopping a procedure or process when an SOP or product quality is in question.
Initiate and complete reports in a timely manner.

At 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.

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.
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 employees on quality system requirements and problem solving.
Compiles and creates periodic reports for management.
Ensure compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
Adheres to company safety requirements.
Demonstrates initiative and job knowledge by suggesting ideas, discovering new and better ways of accomplishing goals, and finds innovative, well thought-out solutions to problems.
Takes initiative and makes 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.

Bachelor’s degree with four years of related experience; or equivalent combination of education and experience.
Ability to effect change in a positive environment. Must be able to provide constructive arguments and sound justification as it pertains to technical and supplier requirements.
Initiates and completes reports in a timely manner.
Works independently with little direction or oversight, in a fast-paced environment.
Schedules projects and meets tight deadlines.
Ability to travel 5 - 10%.

About the Company

Thorne

Purity-focused nutritional supplements with scientific rigor

Thorne is a health and wellness company that makes nutritional supplements. It focuses on purity and scientific backing, testing its products to ensure quality and efficacy for consumers. Its products work by delivering carefully studied nutrients and other ingredients in supplements that people take to support their health. Thorne differentiates itself from competitors through a long history dating back to 1984, a strong emphasis on quality and scientific integrity, and rigorous quality controls. In 2023 the company was acquired by L Catterton, moved off public markets, and continues to pursue growth by expanding research and development. The overall goal is to provide reliable, high-quality supplements that people can trust to support their health and well-being.

Company size: 501-1,000
Company stage: IPO
Headquarters: New York City, United States
Founded: 1984

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