Remote Quality Audit Specialist – QMS & Compliance

LabConnect

Oregon

Hybrid

USD 90,000 - 120,000

Full time

7 days ago
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Benefits offered by this job

401k Match
Health Benefits
PTO + Holidays
Disability Insurance
AD&D
Volunteer day

Job summary

LabConnect is a global provider of central laboratory services and FSP solutions, partnering with pharma and biotech firms to support clinical trials worldwide. The Quality Audit Specialist will drive audits, support regulatory compliance, and collaborate with cross-functional teams to maintain quality across our operations.

This fully remote role allows you to work from anywhere in the United States while ensuring GCP compliance and continuous improvement of the quality management system.

Qualifications

  • Bachelor's degree in a quality or scientific field.
  • 4–6 years of experience in quality-related roles, with regulatory audits.
  • Experience conducting clinical trials audits.
  • eQMS software experience preferred (Veeva Vault).

Responsibilities

  • Schedule and perform internal and external audits (QRS or clients).
  • Lead audit preparations and post-audit actions.
  • Maintain QMS documents, controls, and records.
  • Track, trend, and report audit findings and CAPAs.
  • Coordinate with project teams and vendors.
  • Prepare audit reports and metrics for management.
  • Provide regulatory guidance and audit readiness training.
  • Act as QRS representative in internal/external meetings.

Skills

Attention to detail
Planning
Problem-solving
Organization
Time management
Communication
Audit readiness

Education

Bachelor's degree in related field
4-6 years quality experience
Experience with clinical trials audits

Tools

Veeva Vault

Job description

LabConnect is a global provider of central laboratory services and FSP solutions, partnering with pharma and biotech firms to support clinical trials worldwide. The Quality Audit Specialist will drive audits, support regulatory compliance, and collaborate with cross-functional teams to maintain quality across our operations.

This fully remote role allows you to work from anywhere in the United States while ensuring GCP compliance and continuous improvement of the quality management system.

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