QA Auditor - 205417

Medix™; Rockville (MD); Vor Ort; USD 110.000 - 160.000; Vollzeit

Zusammenfassung

Medix is seeking an experienced Quality Assurance professional to plan, execute, and document GCP audits of clinical sites, CROs, vendors, TMFs, and internal quality systems. You will develop audit plans, reports, findings, and closure records, and support CAPA management and regulatory readiness.

The ideal candidate holds a Bachelor’s in Life Sciences and has at least five years in QA within biotech/pharma/clinical research, including three years of GCP auditing across sites, CROs, and vendors.

Qualifikationen

• Bachelor’s degree required in life sciences or related field.
• Minimum five years of QA experience in biotech/pharma/clinical research.
• At least three years of GCP auditing experience including sites, CROs, and vendors.
• Strong knowledge of ICH GCP, FDA regulations, and quality systems.
• Experience with CAPA, root cause analysis, and risk-based auditing.
• Excellent written and verbal communication; strong organizational skills.

Aufgaben

• Plan, execute, and document GCP audits of clinical sites, CROs, vendors, 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 CAPA plans.
• Confirm timely implementation and effectiveness of corrective and preventive actions.
• Ensure compliance with applicable GCP, GLP, GMP, FDA, ICH, and other regulatory standards.
• Assist 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.

Kenntnisse

GCP auditing

CAPA management

Regulatory knowledge

Communication

Ausbildung

Bachelor’s degree in Life Sciences/related field

Jobbeschreibung

• 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.