Primary Responsibilities :

• Perform investigations per established procedures
• Generate quality records as needed (CAPAs, CCs) to support process improvements
• Review laboratory records (test packets, logbooks, etc.) and ensure they have

acceptable Good Documentation Practices and are following procedures

• Update and draft standard operating procedures and work instructions
• Communicate effectively with all team members

Minimum Qualifications :

• Bachelor’s Degree in a scientific, engineering, or other technical discipline
• 4 years of experience in a quality assurance setting
• Direct experience in record review, investigations, and root cause analysis
• Good understanding and compliance with principles of Good Documentation Practices
• Strong organizational and time management skills
• Excellent attention to detail
• Strong analytical skills
• Succeed when working independently and as part of a team
• Demonstrated work ethic and accountability

Preferred Qualifications :

• Experience working within a quality system (e.g. Veeva)
• Thrive in a fast paced, growing, and dynamic work environment

Last updated : 2024-06-19