Quality Assurance Manager

Job Summary
Quality Assurance (QA) Manager’s primary duty is to maintain appropriate oversight of cGMP processes to ensure the quality of produced pharmaceutical and nutraceutical products. Responsibilities include managing and monitoring quality assurance personnel systems, providing oversight for processes and facilities to ensure regulatory compliance in the manufacture of pharmaceutical and nutraceutical products, ensuring comprehensive technical and administrative review of the batch and analytical data generated by manufacturing and cGMP test laboratories relating to raw material, in-process and product release, managing and monitoring final batch disposition of manufactured products and participating in investigations and corrective action identification and implementation process for deviations, change controls, and non-conformances. Additionally, oversight in establishing process validation and the implementation of IQ/OQ is expected.

Responsibilities

• Develop, implement, and maintain Quality Management Systems (QMS) to ensure compliance with cGMP, FDA, NSF, Health Canada, and other regulatory requirements.
• Lead internal and external audits, including FDA, NSF, and customer audits, and ensure corrective actions are implemented effectively.
• Manage the development and review of Standard Operating Procedures (SOPs) related to quality and regulatory compliance.
• Oversee product testing and documentation review to ensure adherence to quality standards.
• Monitor and evaluate raw materials, in-process production, and finished products for compliance with specifications.
• Implement and maintain CAPA (Corrective and Preventive Action) programs, OOS (Out of Specification) investigations, and root cause analysis.
• Collaborate with cross-functional teams including R&D, Production, and Supply Chain to support quality initiatives and continuous improvement efforts.
• Ensure proper training and development of QA personnel to maintain high standards of quality.
• Manage complaints, deviations, and non-conformance investigations, ensuring timely resolution and reporting.
• Stay updated on industry regulations, guidelines, and best practices to maintain compliance and improve processes.

Education

• Bachelor’s degree in food science, Chemistry, Biology, or a related field.

Experience

• Minimum of 5-7 years of experience in a QA role within the nutraceutical, pharmaceutical, or food industry, with at least 3 years in a managerial position.

Knowledge, Skills, and Abilities

• Strong knowledge of cGMP, FDA, NSF, HACCP, and other regulatory requirements applicable to nutraceuticals.
• Experience with audits, regulatory inspections, and compliance programs.
• Proficiency in quality management systems, risk assessment, and CAPA processes.
• Excellent problem-solving skills and attention to detail.
• Strong leadership and team management abilities.
• Effective communication and interpersonal skills to collaborate across departments.
• Ability to work in a fast-paced environment and manage multiple priorities.
• Experience with Health Canada regulations and Site License requirements.
• Knowledge of dietary supplement formulation and manufacturing processes.

Certification or License

• HACCP Certification or the ability to obtain certification in the first 6 months
• PCQI Certification or the ability to obtain certification in the first 6 months
• Six Sigma, or ASQ Certified Quality Auditor (CQA).

Join us in our commitment to delivering high-quality products that exceed customer expectations while fostering an environment of continuous improvement.

Job Type: Full-time

Pay: $75,000.00 - $80,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday
• Weekends as needed

Work Location: In person

Salary : $75,000 - $80,000