Responsibilities

• Lead and manage laboratory staff, providing guidance and support to ensure efficient operations.
• Develop, implement, and maintain quality systems in accordance with ISO 9001 standards.
• Ensure compliance with HACCP, FDA regulations, and CGMP requirements.
• Oversee project management activities within the laboratory, ensuring timely completion of projects.
• Conduct regular audits and assessments to ensure adherence to quality control protocols.
• Collaborate with cross-functional teams to address quality-related issues and implement corrective actions.
• Train laboratory personnel on best practices for quality management and safety procedures.
• Fabricate and validate laboratory processes to enhance efficiency and accuracy.

Experience

• Proven experience in a laboratory management role, preferably within a regulated environment.
• Strong knowledge of quality systems, including ISO 9001, HACCP, and CGMP.
• Familiarity with FDA regulations related to laboratory operations.
• Demonstrated experience in project management within a laboratory setting.
• Excellent organizational skills with the ability to manage multiple tasks effectively.
• Strong analytical skills and attention to detail in quality control processes.
• Effective communication skills to collaborate with team members and stakeholders.