Quality Assurance Associate

Job Title: QA Associate

Location: Remote - EST

Duration: 06 months

Pay Range: $(35.50 – 43.11)/hr on W2 all-inclusive without benefits

Shift timings: 7:30 AM 4:30 PM EST


Job Description:

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.


Required Qualifications:

  • 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:

  • 21 CFR 820 and 812
  • ISO 13485, 14971, 15189
  • CLIA, cGMP, GCP
  • EU IVDR (In Vitro Diagnostic Regulation)
  • Proficiency in audits, compliance documentation, and stakeholder engagement.
  • ASQ CQE/CQA certification is advantageous.


Preferred Qualifications:

  • 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.