Job Summary:
The Associate Director of Quality will oversee all aspects of quality assurance (QA) and quality control (QC) within the dietary supplement manufacturing process. This role is crucial in ensuring that all products meet regulatory, safety, and quality standards. The Associate Director of Quality will work closely with cross-functional teams, including production, R&D, and regulatory affairs, to develop, implement, and maintain quality systems and procedures.
Key Responsibilities:
- Quality Management System (QMS): Develop, implement, and manage the Quality Management System to ensure compliance with FDA regulations, GMP (Good Manufacturing Practices), and other relevant standards.
- Quality Assurance and Control: Oversee all QA and QC activities, including raw material testing, in-process testing, and final product testing. Ensure that quality control procedures are strictly followed and that any deviations are documented and investigated.
- Regulatory Compliance: Ensure compliance with all applicable regulatory requirements, including FDA, NSF, and other relevant agencies. Prepare for and manage internal and external audits and inspections.
- Document Control: Maintain accurate and up-to-date documentation, including standard operating procedures (SOPs), batch records, and product specifications. Ensure that all records are properly managed and easily accessible for audits and inspections.
- Continuous Improvement: Lead initiatives to continuously improve quality systems and processes. Implement corrective and preventive actions (CAPA) to address quality issues and prevent recurrence.
- Team Leadership: Manage and mentor a team of quality professionals, including QA/QC analysts and specialists. Provide training and development to ensure that the team stays current with industry best practices and regulatory requirements.
- Supplier Quality Management: Oversee the qualification and monitoring of suppliers to ensure that raw materials meet quality standards. Conduct supplier audits and manage supplier quality issues.
- Product Release: Review and approve product release documentation, ensuring that all products meet quality and safety standards before being released for distribution.
- Risk Management: Identify potential quality risks and develop strategies to mitigate them. Conduct risk assessments and implement risk management plans.
Qualifications:
- Education: Bachelor’s degree in Chemistry, Biology, Food Science, Pharmaceutical Science, or a related field. A Master’s degree is a plus.
- Experience: At least 5-8 years of experience in quality assurance/quality control, preferably in the dietary supplement, pharmaceutical, or food industry. At least 3 years in a leadership role.
- Knowledge: In-depth knowledge of FDA regulations, GMP standards, and other relevant quality standards. Experience with quality management systems, regulatory compliance, and risk management.
- Skills: Strong analytical and problem-solving skills. Excellent communication and leadership skills. Ability to work collaboratively with cross-functional teams. Proficiency in using quality management software and Microsoft Office Suite.
- Certifications: Quality-related certifications such as Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Certified Quality Engineer (CQE), RAPS, are a plus.
Benefits:
- Competitive salary and performance-based bonuses
- Health, dental, and vision insurance
- 401(k) retirement plan with company match
- Paid time off and holidays
- Professional development and training opportunities
Job Type: Full-time
Pay: $75,000.00 - $95,000.00 per year
Experience:
- Leadership: 2 years (Required)
Ability to Commute:
- Alpharetta, GA 30005 (Preferred)
Ability to Relocate:
- Alpharetta, GA 30005: Relocate before starting work (Preferred)
Work Location: In person
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