Quality Assurance Specialist

Responsibilities

• Ensure Compliance with GMP regulations throughout the manufacturing process.
• Conduct regular audits and inspections to verify adherence to GMP standards.
• Develop and implement strategies to continuously improve GMP compliance.
• Maintain and improve the company’s quality management system (QMS).
• Identify areas for process improvement and implement effective quality control measures.
• Collaborate with cross-functional teams to ensure alignment with quality objectives.
• Lead investigations into quality issues and non-conformances.
• Develop CAPA plans to address root causes and prevent recurrence of quality issues.
• Monitor and track the implementation of CAPAs to ensure effectiveness.
• Investigate deviations from established procedures and specifications.
• Develop, review, and update SOPs to reflect current best practices and regulatory requirements.
• Provide training and support to employees on SOPs and quality processes.
• Drive continuous improvement through quality metrics trending, training support, and ensuring sustained GMP compliance across operations.

Qualifications

• Previous experience working in a manufacturing environment, preferably in a regulated industry (e.g., pharmaceuticals, medical devices, food).
• Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements (e.g., FDA, ISO).
• Experience with quality systems management, CAPAs, deviations, document control, and SOPs.
• Excellent analytical and problem-solving skills.
• Effective communication and collaboration abilities.
• Must be able to read, write, and speak in English.
• Detail-oriented with a commitment to quality and compliance.