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AI Summary
The QA and Auditing Lead will own and maintain the company's quality management system while leading internal audits and quality investigations. They are responsible for overseeing batch releases, managing supplier quality, and ensuring regulatory compliance across all manufacturing processes.
What you'll do
- Own and maintain the company quality management system, ensuring it remains current, effective, and aligned with regulatory requirements
- Plan and execute internal audits and lead quality investigations from initiation through closure, acting as project owner and/or project manager
- Train internal teams and suppliers on quality systems, SOPs, and company processes. Conduct supplier and manufacturing facility management activities, including onboarding audits and ongoing quality oversight
- Travel frequently to manufacturing facilities as business needs require, including audits and technical transfers between sites
- Oversee raw material receiving, qualification, and release activities
- Review and approve Certificates of Analysis, batch records, and all documentation required prior to batch release
- Track, investigate, and trend customer complaints related to product quality and quality metrics
- Lead product registration activities where required and support regulatory-driven label updates
- Ensure accurate documentation, recordkeeping, and data integrity across all quality activities
- Communicate effectively with cross-functional stakeholders and follow quality actions through to completion
- Develop and maintain Quality dashboards and reporting tools to track key Quality indicators and ensure continuous improvement of the Quality Management System
- Reviewing and approving product labels
- Registration of Mitra9 products and product certifications (where applicable)
- Conducting GMP trainings and product claims reviews
Qualifications
- At least 7 years of experience in quality.
- At least 3 years of experience auditing companies and managing quality management systems
- At least 2 years of hands-on experience with batch record review and batch release
- Experience in the CPG industry; nutraceutical experience strongly preferred
- Comfortable working in a fast-changing environment with evolving priorities
- Enjoys challenging work that requires research to support business decisions
- Strong interest in regulatory compliance, including continuously reviewing interstate laws and adapting quickly to labeling or regulatory changes
- Detail-oriented professional who enjoys reading, research, and doing things correctly
- Clear and effective communicator who works well with cross-functional stakeholders
- Team player who takes ownership of tasks and follows them through to completion
- Drive the development and maintenance of Quality performance metrics, including defining monthly KPIs for the Quality unit (such as deviations, CAPA, supplier performance, complaints, batch release timelines, and audit outcomes). Lead the monthly Quality metrics review process and present results to leadership, providing clear visibility into Quality performance, trends, risks, and improvement opportunities.
- Strong sense of urgency and accountability
- Ability to travel frequently as business needs require
Preferred:
- Highly detail-oriented with a strong quality mindset
- Comfortable owning projects independently while collaborating with leadership
- Adaptable, organized, and results-driven
- Enjoys building and improving systems rather than maintaining the status quo
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