Quality Assurance Specialist

Job Description

Job Description

Quality Assurance Specialist

Position Summary

The Quality Assurance Specialist is responsible for ensuring product quality, maintaining regulatory compliance, and supporting quality standards throughout the manufacturing process. This role involves inspecting materials and finished products, reviewing production documentation, assisting with audits, and investigating quality issues to ensure compliance with cGMP, FDA, NSF, and other applicable requirements.

The ideal candidate is detail-oriented, organized, and experienced in quality assurance within a manufacturing environment.

Key Responsibilities

• Conduct inspections of raw materials, packaging materials, in-process production, and finished products.
• Ensure manufacturing processes comply with cGMP guidelines, FDA regulations, NSF standards, and other applicable quality requirements.
• Review and maintain batch records, inspection logs, and quality documentation to ensure accuracy and traceability.
• Identify, document, and investigate quality issues, product deviations, and customer complaints.
• Assist with corrective and preventive actions (CAPA) to address quality concerns and prevent recurring issues.
• Support internal and external audits, regulatory inspections, and compliance activities.
• Monitor manufacturing processes to identify potential quality risks and opportunities for improvement.
• Collaborate with Production, Research & Development (R&D), and Regulatory teams to resolve quality and compliance issues.
• Maintain accurate records and ensure quality procedures are followed consistently.
• Promote continuous improvement and adherence to established quality standards.

Qualifications

• Previous experience in Quality Assurance or Quality Control, preferably in a manufacturing environment.
• Knowledge of cGMP guidelines and FDA regulatory requirements.
• Experience with quality inspections, documentation, audits, and compliance procedures.
• Strong attention to detail and organizational skills.
• Ability to investigate issues, identify discrepancies, and support corrective actions.
• Strong communication and problem-solving skills.
• Ability to work collaboratively with cross-functional teams.

Preferred Experience

• Experience with CAPA, deviations, and quality investigations.
• Familiarity with batch records, manufacturing documentation, and audit preparation.
• Experience in a regulated manufacturing industry, such as pharmaceuticals, dietary supplements, food, cosmetics, or medical devices.

Ideal Candidate

The ideal candidate is detail-oriented, proactive, and committed to maintaining product quality and regulatory compliance. They should be comfortable reviewing documentation, identifying potential issues, and working with multiple departments to ensure manufacturing standards are consistently met.

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