Quality Control Manager

As the Quality Control Manager, you will lead and guide the QC department, providing hands-on direction and support in various quality-related activities. You will report directly to the Director of Quality.

Core Position Responsibilities

• Ensure compliance with Catalyst cGMP (21 CFR Part 111 & 117).
• Establish, manage, and oversee Quality Control work centers.
• Oversee the scheduling and duties of the entire QC team.
• Develop and implement enhanced quality reporting measures, including raw material analysis and testing.
• Maintain accurate trackability and traceability of incoming and outgoing materials/products.
• Set, implement, and manage quality processes.
• Support the organization and management of Catalyst lab activities, including materials, , workflows, and testing per cGMP SOPs.
• Coordinate with Catalyst customers and third-party testing partners to provide necessary documentation (e.g., COAs, micro testing, manufacturing declarations).
• Assist in establishing expiration dating analyses.
• Conduct training on all aspects of Quality Management Systems.
• Maintain an “Audit any day” perspective within Quality work centers.
• Manage inventory of retain samples.
• Investigate quality issues in production and implement corrective and preventive actions (CAPA).
• Monitor production issues closely and execute processes to address potential problems.
• Lead cGMP efforts.
• Conduct internal audits and assist in preparing for external audits.
• Monitor manufacturing at every production stage and authorize the release of high-standard quality products.
• Autonomous and quick pivoting for relaying of information, changes in priority of work load, and back up for QC supervisors.

Experience

• Minimum of 5 years of management experience in a regulated industry such as Dietary Supplements, Pharmaceuticals, Medical Devices, Food, or a similar highly regulated field.
• Proficient in Excel and Power Point.
• Proficient in ERP systems.

Education

• Bachelor’s degree required.

Work Authorization

• Must be authorized to work in the United States.

Position Overview

The Quality Control Manager is a critical role responsible for overseeing and managing the Quality Control (QC) department’s daily functions. This position ensures that all quality strategies, tactics, programs, and product disposition activities are executed efficiently and in compliance with regulatory standards.