Quality Review Specialist

15 hours, 40 minutes ago
Full-time
Junior
Quality Assurance and Testing
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised

Description

  • Perform periodic TMF Quality Reviews for assigned projects in a timely manner and with high quality.
  • Evaluate the completeness status of study TMFs and support audit-ready TMF maintenance.
  • Ensure documentation related to periodic TMF Quality Reviews is generated and filed in the TMF.
  • Inform the TMF Lead when TMF information on countries, sites, contacts, and applicable document requirements is incomplete or outdated.
  • Monitor and escalate document processing issues, inconsistencies, missing or incorrect filings, and non-responses from Functional Leads.
  • Support updates to expected documents and opening of TMF placeholders during periodic Quality Reviews.
  • Identify potential training needs for team members working in the TMF to support consistent maintenance.
  • Escalate studies at serious risk based on poor quality to TMF leadership, with manager support.

Requirements

  • Bachelor’s degree or international equivalent plus 2 years of related experience.
  • Established experience and fluency with Microsoft Office, including Outlook, Word, Excel, and PowerPoint.
  • Experience with eTMF systems and vendors.
  • Working knowledge of FDA and ICH/GCP regulations and guidelines.
  • Ability to learn and retain working knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance.
  • Solid interpersonal skills.
  • Strong organizational skills, time management, and ability to coordinate workload and meet deadlines.
  • Ability to identify issues and escalate appropriately and effectively.
  • Self-motivated, detail-oriented, and able to work independently as well as in a team environment.
  • Professional verbal and written communication skills.

Benefits

  • Equal Opportunity Employer status with non-discriminatory employment practices.
  • Reasonable accommodation support for candidates with disabilities during the application process.
  • Alternative application method available by contacting [email protected].

Interested in this position?

Apply directly on the company website

Apply Now

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