Quality Assurance Specialist

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Requirements:

• Bachelor’s degree or equivalent experience.
• Sound working knowledge of medical terminology, SOPs, ICH, GCP, FDA, regulatory requirements, and quality management processes.
• 3-5 years prior work experience in clinical quality, compliance or auditing roles.
• Direct experience in the conduct and reporting of internal and external audits preferred.
• Experience with GCP inspections and partner audits preferred.
• Clinical Research or Quality Certification preferred.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to work independently, take initiative, and manage multiple tasks with attention to detail.
• Proficient in Microsoft Office programs.

Responsibilities:

• Travel to M3 Wake Research sites to conduct internal quality assurance reviews of clinical trials and processes for adherence to SOPs, company policy, and regulations/standards.
• Prepare reports and discuss non-compliance and/or quality findings with internal customers as well as with Quality management.
• Track and follow up on the resolution of review findings.
• Provide guidance to clinical staff in resolving findings and implementing processes and CAPA plans.
• Assist in preparing for inspections by sponsors and regulatory agencies and participate in site inspections as appropriate.
• Assist in implementing quality management plans, risk identification, and assessment.
• Provide consultation on corrective and preventive actions, follow up on their effectiveness.
• Assist in developing training materials and conducting trainings for employees and new hires.
• Review training records for compliance.
• Stay updated on clinical trial requirements and escalate significant compliance issues.