QA Auditor - 205417

Responsibilities:

• Plan, execute, and document GCP audits of clinical sites, CROs, vendors, Trial Master Files (TMFs), and internal quality systems.
• Conduct vendor qualification and periodic requalification audits.
• Assist with GLP, GMP, and quality system audits as needed.
• Develop and maintain audit documentation, including audit plans, reports, findings, and closure records.
• Evaluate audit responses, root cause investigations, and Corrective and Preventive Action (CAPA) plans.
• Confirm the timely implementation and effectiveness of corrective and preventive actions.
• Ensure compliance with applicable GCP, GLP, GMP, FDA, ICH, and other regulatory standards.
• Assist with regulatory inspection preparation and inspection-readiness activities.
• Provide quality and compliance support to cross-functional teams.
• Support continuous improvement initiatives and maintain quality assurance procedures and documentation.
• Perform additional duties as assigned.

Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Chemistry, Biology, or a related scientific field.
• Minimum of five years of Quality Assurance experience within the biotechnology, pharmaceutical, or clinical research industry.
• At least three years of GCP auditing experience, including clinical sites, CROs, and vendors.
• Working knowledge of ICH GCP guidelines, FDA regulations, and clinical quality systems.
• Experience with CAPA management, root cause analysis, and risk-based auditing practices.
• Strong written and verbal communication skills.
• Excellent organizational, analytical, and problem-solving abilities.