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Senior QA Specialist

4 months ago
United States
Full-time
Senior
Manual QA Tester
Quality Assurance and Testing
Apply Now
EDETEK

EDETEK

EDETEK Inc. is a premier provider of digital clinical trial systems, offering innovative solutions to streamline data collection and analysis for pharmaceutical and biotech companies.

Internet Software & Services
51-250
Founded 2009
View All Jobs 7

Description

  • Conduct and host internal audits, vendor audits, project/study audits, and inspection readiness assessments.
  • Review Trial Master Files for completeness, accuracy, and compliance.
  • Track audit findings, deviations, nonconformances, and CAPAs through resolution and effectiveness checks.
  • Review, develop, and maintain SOPs, policies, work instructions, forms, and other QMS documents.
  • Support training management by establishing, reviewing, and monitoring training curricula and overdue training.
  • Participate in computer system validation planning, execution, documentation, and re-validation activities.
  • Review validation plans, requirements specifications, risk assessments, test scripts, protocols, traceability matrices, and summary reports.
  • Ensure systems and processes comply with GxP, ICH-GCP, 21 CFR Part 11, Annex 11, and internal quality standards.
  • Serve as a QA liaison across Biometrics, Software Development, IT/Security, and other cross-functional teams.
  • Support pre-inspection readiness for regulatory audits and respond to client quality inquiries and due diligence questionnaires.
  • Lead or contribute to risk assessments, quality metric reviews, and continuous improvement initiatives.

Requirements

  • Bachelor’s degree in life sciences, computer science, or a related field.
  • Minimum of 5 years of QA experience in clinical research, clinical systems, or regulated software environments.
  • Strong knowledge of GxP, ICH-GCP, 21 CFR Part 11, Annex 11, and SDLC principles.
  • Proven experience conducting audits and managing CAPAs.
  • Excellent documentation and communication skills.
  • Ability to communicate effectively in English, both spoken and written.
  • Ability to work independently, take initiative, and meet deadlines.
  • Ability to prioritize and execute tasks in a high-pressure environment.
  • Demonstrated collaboration skills across diverse teams and functions.
  • Proficiency with Microsoft Office applications.
  • Preferred: Experience in a company offering eClinical or biometric services.
  • Preferred: Familiarity with electronic QMS platforms such as ZenQMS.

Benefits

  • Competitive benefits that vary by country, with a U.S. benefits package available.
  • Choice of comprehensive Medical, Vision, and Dental insurance plans.
  • Paid vacation time and sick days.
  • Corporate holidays annually.
  • 401(k) plan participation.
  • Discount and perk programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, and more.
  • Health Advocate and Employee Assistance Program.
  • Remote position open to candidates based in the United States.

Interested in this position?

Apply directly on the company website

Apply Now

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