Quality Assurance Specialist
The role of Quality Assurance Specialist is to ensure that all quality-related processes and systems are in place and functioning effectively. This includes ensuring compliance with regulatory requirements, maintaining accurate records, and implementing corrective actions as needed.
About the Job
This position is responsible for managing the site's quality systems, including quality planning, quality control, and quality assurance. The Quality Assurance Specialist will work closely with other departments to ensure that quality objectives are met and that any issues or concerns are promptly addressed.
Responsibilities
• Manage the site's quality systems, including quality planning, quality control, and quality assurance
• Ensure compliance with regulatory requirements, including Good Manufacturing Practices (GMP) and ISO 9001
• Maintain accurate and complete records, including quality records, batch records, and deviation reports
• Implement corrective actions as needed to address any quality-related issues or concerns
• Collaborate with other departments to ensure that quality objectives are met
Requirements
• Bachelor's degree in a relevant field, such as science, engineering, or quality assurance
• Proven experience in quality assurance, quality control, or a related field
• Strong understanding of regulatory requirements, including GMP and ISO 9001
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
Preferred Qualifications
• Certification in quality assurance, quality control, or a related field
• Experience with quality management software
• Familiarity with industry standards and best practices
• Strong analytical and problem-solving skills