Quality Assurance Specialist I

Responsibilities

• Partner cross-functionally with Purchasing, Engineering, Planning, R&D, Sales, and Quality teams to support contract manufacturing activities and maintain supply chain quality and integrity.
• Investigate, coordinate, and resolve supplier quality issues, including root cause analysis, corrective actions, and follow-up activities.
• Maintain and communicate supplier quality and complaint status reports to stakeholders.
• Coordinate supplier qualification activities, including supplier approvals/disapprovals, quality agreements, and supplier audits.
• Conduct onsite and remote audits of contract manufacturers and key suppliers to ensure compliance with quality standards and regulatory requirements.
• Monitor and review product stability data for both normal and accelerated studies; communicate any trends, anomalies, or potential risks to Quality Management and key stakeholders.
• Support continuous improvement initiatives by identifying opportunities to streamline systems, strengthen processes, and improve overall product quality.
• Write, review, and revise SOPs, specifications, controlled forms, and related quality documentation to ensure accuracy, compliance, and alignment with current operations.
• Coordinate CAPA activities, including meetings, documentation management within EtQ, root cause investigations, and development of corrective and preventive actions.
• Perform raw material evaluations to assess alignment between supplier specifications and internal requirements, identifying and communicating potential quality risks.
• Conduct Product Quality Reviews (PQRs) for Australia products and designated Thorne core products.
• Participate in cross-functional process improvement teams, ensuring quality considerations and documentation requirements are properly addressed.
• Maintain accurate, detailed, and compliant records and documentation.
• Demonstrate sound judgment and a commitment to product quality, including the ability to stop a process or procedure when quality or SOP compliance is in question.
• Adhere to company safety standards and contribute innovative ideas to improve processes, systems, and overall quality performance.

Requirements

• Bachelor’s degree with two 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.
• Schedules projects and meets tight deadlines.
• Ability to travel up to 5 - 10% of the time.

Qualifications

• Strong communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Knowledge of quality management systems and cGMPs.
• Experience with Microsoft Office Suite.
• Basic understanding of statistical process control (SPC).

Skills

• Quality assurance and quality control techniques.
• Supplier management and auditing.
• Stakeholder engagement and project management.
• Statistical analysis and data interpretation.
• Effective written and verbal communication skills.

Benefits

• 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

Pay

• Competitive compensation

Schedule

• Full-time