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Job Details

All Jobs / Req# NOVPJP00004263
Req Number:
NOVPJP00004263
Req Title:
Precision Medicine QA Associate
Client:
A Major Pharma Company
Work Address:
Remote
Req Release Date:
03/02/2026
Duration:
6 months
Hours a week:
37.5 Hours
Position Summary

Primary Responsibilities:

  • Provide operational and quality support across strategic initiatives and workstreams within Precision Medicine program team and PM QA.
  • Collaborate with the PM QA lead to evaluate current QA processes, identify gaps, and co-drive improvement efforts to strengthen compliance, efficiency, and documentation standards.
  • Facilitate cross-functional project management meetings, manage action tracking, and oversee project timelines and deliverables.
  • Develop and maintain high-quality documentation, reports, and presentations for internal and external stakeholders.
  • Support risk monitoring, audit readiness, and CAPA activities, ensuring alignment with global regulatory and GxP requirements.
  • Contribute to broader CQA team initiatives and workstreams as needed.

 

Shift Timings: 7:30 AM - 4:30 PM EST.

Qualifications:

Required:

  • Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline.
  • 3-5 years of experience in Quality Assurance or Engineering within IVD, Medical Devices, or Diagnostics, including embedded software and manufacturing.
  • Demonstrated experience in drug development, clinical trials, and diagnostic laboratory settings.
  • Strong working knowledge of:
    1. 21 CFR 820 and 812
    2. ISO 13485, 14971, 15189
    3. CLIA, cGMP, GCP
    4. EU IVDR (In Vitro Diagnostic Regulation)
  • Proficiency in audits, compliance documentation, and stakeholder engagement.
  • ASQ CQE/CQA certification is advantageous.

 

Preferred:

  • Experience in GxP-regulated environments and familiarity with global regulatory frameworks (FDA, EMA, ICH).
  • Proven ability to work effectively in matrixed and global team structures.
  • Clinical QA experience is an added advantage.
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