GCP Auditor

20 hours, 9 minutes ago
Full-time
Junior
Quality Assurance and Testing
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012

Description

  • Support the Quality Management System, including SOPs, training, and CAPA activities.
  • Process and maintain controlled document documentation.
  • Develop and administer training for employees and consultants.
  • Host client and sponsor audits and support regulatory inspections.
  • Coordinate and conduct vendor assessments and vendor audits.
  • Coordinate and conduct internal quality system audits.
  • Coordinate and conduct investigator site audits.
  • Coordinate and conduct trial master file audits.
  • Participate in computer systems validation projects and change control processes.
  • Provide QA consultation, manage quality issues and corrective/preventive actions, and monitor compliance risks.

Requirements

  • Bachelor’s degree in a science, healthcare, or related field, or equivalent relevant experience.
  • Extensive working knowledge of audit management in a clinical trials environment, including GCP, CRO process, and vendor audits.
  • Working knowledge of GCP/ICH guidelines and FDA regulations and standards.
  • Availability to travel up to 25% domestically and/or internationally.
  • 2+ years of experience in a QA GCP department in a related industry (preferred).
  • QA certification such as CQA or SQA preferred.
  • Experience with electronic clinical trial systems such as EDC, CTMS, IxRS, and ePRO preferred.

Benefits

  • Fully remote position.
  • Opportunity to work on groundbreaking cancer therapies and rare disease programs.
  • Employee ideas are valued and encouraged, with room to contribute to positive change.
  • Equal opportunity employer with accommodations available for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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