Quality Control Inspector

Roles & Responsibilities

• Review and ensure the accuracy and completeness of medical records, surgical records, protocols, and study data.
• Collaborate with staff to identify, evaluate, and recommend solutions to review and correct findings.
• Draft study deviations in a timely manner and incorporate Study Director impact assessments.
• Perform audits of protocol, SOP, and quality system elements to ensure compliance with GLP regulations and internal procedures.
• Ensure preclinical in-vivo studies are compliant with GLP regulations (21 CFR Part 58) and adhere to internal quality guidelines.
• Identify and report basic non-compliance within regulations and standards.
• Collaborate efficiently with different groups, managing movements between various locations around the site according to stakeholder schedules.

Experience Required

• Preferred: Bachelor’s degree with 3 years of preclinical medical device research experience, or 5 years of relevant work experience supporting preclinical research (e.g., LAR/surgical vet tech).
• Background in data management and familiarity with medical device GLP research.
• Demonstrated understanding in the use of calibrated equipment, controlled drugs, and GLP data collection/retention.

Skills & Certifications

• Excellent attention to detail.
• Strong data management skills.
• Ability to collaborate effectively with various teams and stakeholders.
• Proficiency in adhering to and enforcing compliance with GLP regulations and internal procedures.

Eligibilities & qualifications

• Preferably holds a Bachelor’s degree with 3 years of experience in preclinical medical device research or 5 years of relevant work experience supporting preclinical research.
• Demonstrated understanding of calibrated equipment, controlled drugs, and GLP data collection/retention.
• Must be able to identify basic non-compliance within regulations and standards.