Quality Control Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, implement, and continuously enhance Supergut’s internal Quality Management System.

• Create and maintain specifications for raw materials, finished products, packaging components, standard operating procedures (SOPs), and quality manuals.

• Oversee document control processes, including revision tracking and controlled documentation systems.

• Establish and manage procedures for change control.

• Ensure that quality systems are consistently audit-ready.

• Guarantee Supergut's compliance with dietary supplement cGMP requirements as outlined in 21 CFR 111.

• Establish and supervise processes for finished product testing and release.

• Review and approve Certificates of Analysis (COAs), analytical testing reports, and batch documentation for release verification.

• Maintain systems for traceability and release documentation.

• Ensure adherence to proper documentation retention practices.

• Establish and supervise a compliant finished product retain program.

• Maintain secure and organized storage for retains or oversee third-party retain storage facilities.

• Track retain inventory alongside expiration timelines.

• Conduct periodic organoleptic evaluations of retains as part of ongoing quality monitoring.

• Qualify and approve contract manufacturers, raw material suppliers, and third-party testing laboratories.

• Establish and maintain supplier qualification programs based on risk, primarily involving paper audits and on-site visits.

• Review and manage quality agreements.

• Conduct evaluations of supplier performance.

• Manage and maintain third-party certifications, including but not limited to: Project Non-GMO, Low FODMAP, Vegan, Gluten Free, and other relevant certifications.

⛳️ Requirements

• A minimum of 5 years of experience in Quality Assurance and/or Regulatory Affairs within the dietary supplements industry.

• Strong understanding of FDA dietary supplement regulations (21 CFR 111).

• Proven experience in managing third-party certification programs (e.g., Non-GMO Project, Vegan, Low FODMAP, or similar).

• Experience in overseeing processes for finished product testing and release.

• Background in developing and maintaining stability programs.

• Experience managing retain programs for finished dietary supplement products.

• Proven ability to manage quality systems across multiple contract manufacturers.

• Familiarity with analytical testing methods and coordination with third-party laboratories.

• Bachelor’s degree in Food Science, Chemistry, Biology, or a related field.

🏝️ Benefits

• Unlimited PTO.

• 401(k) match.

• Comprehensive medical, dental, and vision coverage with generous employer contributions.