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Quality Control Lead

2 months ago

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

Position Title: Quality Control Manager

Reporting Line: 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, strategies, 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 units.
  • Manage the scheduling and responsibilities of the entire QC team.
  • Develop and implement advanced quality reporting systems, including raw material assessments and testing protocols.
  • Maintain precise tracking and traceability of incoming and outgoing materials/products.
  • Set, implement, and manage quality and production protocols.
  • Collaborate with suppliers to ensure quality, accuracy, and proper documentation.
  • Support the organization and management of Catalyst laboratory activities, 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 analyzing available stability data and results.
  • Conduct training on all aspects of Quality Management Systems.
  • Support investigations into customer complaints and quality-related trends.
  • Maintain a readiness for audits within Quality operational units.
  • Manage the inventory of retained samples and conduct annual product evaluations.
  • Investigate production quality issues and implement corrective and preventive actions (CAPA).
  • Closely monitor production issues and execute processes to address potential challenges.
  • Lead efforts for cGMP and Organic certification, including renewals.
  • Conduct internal audits and assist in preparation for external audits.
  • Monitor manufacturing processes at every production stage and authorize the release of high-quality products.

Qualifications

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

Educational Requirements

  • A Bachelor's degree is required.

Work Eligibility

  • Must possess authorization to work in the United States.

Catalyst is an Equal Opportunity Employer