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Quality Assurance Specialist Role

This position plays a pivotal role in ensuring the high quality of clinical studies, guaranteeing compliance with Good Clinical Practice (GCP) and internal quality standards. As a Quality Assurance Specialist, you will be responsible for providing expert support to clinical study teams, ensuring that all activities are conducted in accordance with established protocols.

  • Serve as the primary QA resource for clinical study teams, promoting adherence to GCP and internal quality standards.
  • Participate in study calls, including protocol deviation meetings, risk-based quality management discussions, and study operations and trial oversight meetings, providing valuable insights and guidance.
  • Develop, review, update, and format standard operating procedures (SOPs) and other quality documentation within Veeva QMS, ensuring accuracy and consistency.
  • Manage and track quality processes, respond to QA-related questions from study teams, and provide clear and actionable guidance.
Qualifications and Skills
  • Bachelor's degree in life sciences, healthcare, or a related field.
  • 5+ years of experience in Clinical Quality Assurance, with a strong foundation in GCP.
  • Prior experience supporting clinical study teams in a QA capacity, demonstrating a deep understanding of the importance of quality assurance.
Key Qualities
  • Attention to detail and ability to identify areas for improvement.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
  • Strong analytical and problem-solving skills, with the ability to think critically and develop effective solutions.
  • Able to adapt to changing priorities and deadlines, with a strong work ethic and commitment to delivering high-quality results.

Clinical Quality Assurance experience is crucial for this role. We seek an individual with a proven track record of ensuring quality and compliance in clinical studies.