The Role
Lead supplier quality and audit activities, manage CAPA and change control, investigate complaints and adverse events, oversee stability and PQRs, maintain supplier qualifications and agreements, support regulatory audits and SOPs, and drive continuous quality improvements in a cGMP manufacturing environment.
Summary Generated by Built In
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, 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.
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.
RESPONSIBILITIES
- 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. 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.
WHAT YOU NEED
- Bachelor’s degree with four years of related experience; or equivalent combination of education and experience.
- 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.
- 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%.
WHAT WE OFFER
- Competitive compensation
- 100% company-paid medical, dental, and vision insurance coverage for employees
- Company-paid short- and long-term disability insurance
- Company- paid life insurance
- 401k plan with employer matching contributions up to 4%
- Gym membership reimbursement
- Monthly allowance of Thorne supplements
- Paid time off, volunteer time off and holiday leave
- Training, professional development, and career growth opportunities
About
We specialize in delivering innovative solutions and exceptional services to meet the diverse needs of our clients. With a strong commitment to quality and customer satisfaction, we strive to exceed expectations and drive success in every project we undertake.
Skills Required
- Bachelor's degree with four years of related experience or equivalent combination of education and experience.
- Experience in a cGMP manufacturing environment and familiarity with standard quality concepts, practices, and procedures.
- Ability to lead and work with cross-functional teams and track projects to completion.
- Experience coordinating and conducting supplier audits and supplier qualification processes, including on-site audits.
- Experience with CAPA, root cause analysis, corrective actions, and maintaining CAPA documentation (EtQ mentioned).
- Experience reviewing stability data and conducting Product Quality Reviews (PQRs).
- Strong written communication and documentation skills; ability to write, revise, and approve SOPs and controlled documents.
- Ability to work independently, manage tight deadlines, and initiate process improvements.
- Ability to travel 5-10%.
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The Company
What We Do
We’re a team of dreamers, scientists, doctors, and health enthusiasts – all working toward the same goal – helping every individual discover and achieve their best possible health. We do it by creating innovative health solutions and by owning every process, from R&D to product delivery and customer service. We intend to defy expectations of good health through home testing technology, dietary and lifestyle education, and superior nutritional products.
