Quality Control Manager
1 month ago
Job Title: Quality Control Manager
Reports to: Director of Quality
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.
Position Description
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).
- Establish, manage, and oversee Quality Control and Quality Assurance 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 and production processes.
- Collaborate with suppliers to ensure quality, accuracy, and proper documentation.
- Support the organization and management of Catalyst lab activities, including materials, stock levels, 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 by analyzing available stability data and analyses.
- Conduct training on all aspects of Quality Management Systems.
- Support customer complaint investigations and trending activities related to quality.
- Maintain an “Audit any day” perspective within Quality work centers.
- Manage inventory of retain samples and perform annual product reviews.
- 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 and Organic certification efforts, including renewals.
- 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.
Experience
- Minimum of 5 years of management experience in a regulated industry such as Dietary Supplements, Pharmaceuticals, Medical Devices, or a similar highly regulated field.
Education
- Bachelor’s degree required.
Work Authorization
- Must be authorized to work in the United States.
Catalyst is an Equal Opportunity Employer
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