Senior QA Specialist

3 weeks, 1 day ago
Full-time
Senior
Quality Assurance and Testing
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

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

Similar Roles

Content Operations Specialist

Unity 5K-10K Internet Software & Services

Unity is hiring a Content Operations Specialist to help manage and quality-check Marketplace and content library assets, supporting the flow from submission to publication within a global game-development ecosystem.

C# Unity
4 hours, 48 minutes ago

NDT Inspector Level II

Anduril Industries 1K-5K Aerospace & Defense

Anduril Industries is seeking an NDT Inspector Level II for its Maritime Manufacturing Technology team to inspect defense hardware and support quality assurance in a fast-paced production environment.

12 hours, 13 minutes ago

Junior Auditor (Part-Time, French Language Expertise)

Volga Partners 51-250 Internet Software & Services

Volga Partners is hiring a part-time, project-based Junior Judge / Junior Auditor to support French-language multimedia data labeling, annotation, and quality review work that improves search and data quality across French-speaking markets.

Machine Learning SEO
16 hours, 24 minutes ago

AI Data Quality Control Coordinator

Welo Global Professional Services

Welo Data is hiring a freelance remote AI Data Quality Control Coordinator in Argentina to oversee the quality of annotated datasets used to train and evaluate machine learning models.

Computer Vision Git Machine Learning NLP
18 hours, 7 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers