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

Information Technology

51-250 (180)

Founded 2009

5 open positions

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Senior QA Specialist

1 hour, 47 minutes ago

United States

Full-time

Senior

Manual QA Tester

Quality Assurance and Testing

Apply Now

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 5

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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