Roles and Responsibilities:
- Supervise QA department personnel, focusing on:
- QAG and production process monitoring
- Label Cage operations and personnel
- Protocol review
- Collaboration with Production Supervisors to resolve production issues
- Review of Standard Operating Procedures (SOPs)
- Oversight of environmental condition records and response to deviations
- Ensuring compliance with cGMP requirements, regulations, industry standards, and company policies
- Conducting investigations, assessing and resolving deviations impacting product quality, safety, and purity
- Reviewing Preventive Maintenance (PM), Pest Control, Calibration records, etc.
- Collaborating with Production, New Product Development, and other departments on Quality Systems activities
- Ensuring product quality and adherence to government regulations, industry standards, and company policies
- Implementing processes to ensure compliance with regulations, standards, and company policies
- Ability to work varying shift hours as needed
- Effective communication with other departments and teamwork
- Performing other assigned duties as required
Minimum Requirements: The QA Supervisor should have 3-5 years of experience in an FDA-regulated manufacturing environment, with at least 3 years specifically in Quality Assurance or Quality Control. Prior FDA or equivalent inspection experience is highly advantageous.
Education and Experience: A Bachelor's degree in a Science major or concentration, supplemented by continuing education credits or certifications from a reputable professional society in the pharmaceutical industry. Minimum of 5 years' experience in Quality Assurance within the nutritional supplement and/or pharmaceutical products manufacturing industry.