Manager of Quality Assurance

2 weeks ago


Buford, Georgia, United States Catalyst Nutraceuticals Full time
Job Overview

Position Title: Quality Control Manager

Reporting To: Director of Quality

Role Summary

The Quality Control Manager plays a vital role in supervising and directing the daily operations of the Quality Control (QC) department. This position is essential for ensuring that all quality initiatives, methodologies, programs, and product evaluation activities are carried out effectively and in accordance with regulatory requirements.

Key Responsibilities

  • Ensure adherence to Catalyst cGMP (21 CFR Part 111) standards.
  • Establish and oversee Quality Control and Quality Assurance operational centers.
  • Manage the scheduling and responsibilities of the entire QC team.
  • Develop and implement improved quality reporting systems, including analysis and testing of raw materials.
  • Maintain precise tracking and traceability of incoming and outgoing materials/products.
  • Set, implement, and oversee quality and production protocols.
  • Collaborate with suppliers to guarantee quality, accuracy, and proper documentation.
  • Support the organization and management of Catalyst laboratory operations, including materials, inventory levels, workflows, and testing in compliance with cGMP SOPs.
  • Coordinate with Catalyst clients and third-party testing partners to provide necessary documentation (e.g., Certificates of Analysis, microbiological testing, manufacturing declarations).
  • Assist in determining expiration dates by evaluating available stability data and analyses.
  • Conduct training on all facets of Quality Management Systems.
  • Support investigations of customer complaints and quality-related trends.
  • Maintain a readiness for audits within Quality operational centers.
  • Manage the inventory of retained samples and perform annual product evaluations.
  • Investigate production quality issues and implement corrective and preventive actions (CAPA).
  • Closely monitor production challenges and execute processes to mitigate potential issues.
  • Lead efforts for cGMP and Organic certification, including renewals.
  • Conduct internal audits and assist in preparations for external audits.
  • Oversee manufacturing at every production stage and authorize the release of high-quality products.

Qualifications

  • A minimum of 5 years of management experience in a regulated sector such as Dietary Supplements, Pharmaceuticals, Medical Devices, or a similarly regulated field.

Educational Background

  • A Bachelor's degree is required.

Work Eligibility

  • Must possess authorization to work in the United States.

Catalyst is an Equal Opportunity Employer



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