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16 days ago
Requirements and responsibilities
We are seeking a senior QA specialist who will play a critical role in driving compliance and quality across the organization’s biometric services and computer systems. This role involves hands-on execution of QA activities, leadership in audits and risk management, and close collaboration with cross-functional teams such as data management, biostatistics, statistical programming, software development and validation, and IT and security.The senior QA specialist will ensure that processes, computer systems, and deliverables adhere to GxP, ICH-GCP, 21 CFR Part 11, and other applicable regulations, as well as internal quality standards through proactive oversight, documentation review, system validation, and continuous process improvement.Essential Functions and Responsibilities1. Document & Process AuditingConduct and/or host internal audits and vendor auditsReview and audit Trial Master File (TMF) for completeness, accuracy, and complianceTrack and report audit findings, deviations, and CAPAs (Corrective and Preventive Actions)Perform risk-based audit planning and inspection readiness assessments2. SOPs, Policies and QMS MaintenanceReview and assist in developing policies, SOPs, work practice documents, forms and other Quality Management System (QMS) documentsEnsure alignment with the company’s Quality Policy and applicable external regulationsEnsure controlled documents are reviewed periodically and in a timely mannerDocument and manage deviations, nonconformances, and CAPAsMaintain quality records and support archiving in accordance with regulatory timelines3. Training ManagementCollaborate with functional managers to establish and periodically review training curricula, including study-specific training for internal teamsMonitor overdue training, and follow up with individuals and their supervisors until completion4. Computer System Validation SupportParticipate in validation planning and execution for internal and customer-facing systemsCollaborate with software validation team and IT to review:Computer system validation plan (CVP)Functional/user requirements specifications and risk assessmentsTest scripts, validation protocols (IQ/OQ/PQ), and traceability matricesTest run reports and validations summary reportsReview change requests, bug reports, and ensure re-validation as neededEnsure systems comply with 21 CFR Part 11 requirements, including audit trails, access control, and electronic signatures5. Audit and Inspection ReadinessPlan, execute, and document internal process audits, project/study audits, and vendor audits.Coordinate with IT and product teams to ensure systems and environments are audit-ready by confirming that the following activities are performed in accordance with SOPs:Systems are validated and reviewed in a timely mannerAudit trails and system logs are monitored and reviewedAccess reviews, system related exercises and tests, and security scans are performed periodicallyCoordinate with biometric teams to ensure services are performed in accordance with applicable regulations and EDETEK SOPs, including following QC processes, proper document versioning, review and approval, and appropriate documentation and sign-off for deviationsLead or assist in pre-inspection readiness for regulatory audits (e.g., FDA, EMA, MHRA).Track findings, respond to audit reports, manage CAPAs through resolution and effectiveness checks, and ensure timely completion with evidence retained for review6. Cross-Functional SupportAct as a QA liaison across departments, including Biometrics, Software Development, and IT/Security.Mentor junior QA team members by providing training and peer reviews.Represent QA in project meetings, product releases, and client quality discussions.Respond to client quality inquiries and due diligence questionnaires.7. Continuous ImprovementLead or contribute to risk assessments for clinical projects, software systems, and vendor engagements.Identify quality gaps or inefficiencies and propose remediation or process improvement initiatives.Monitor and analyze quality metrics and trends (e.g., deviation rates, audit findings, CAPA effectiveness).Contribute to QMS improvement projects and ensure effective cross-functional adoption.RequirementsAbility to communicate effectively in English (spoken and written)Ability to work independently, take initiative, and meet deadlinesCapable of prioritizing and executing tasks in a high-pressure environmentDemonstrated collaboration skills across diverse teams and functionsAdaptable and productive in a dynamic, evolving environmentProficiency with Microsoft Office applicationsBachelor’s degree in life sciences, computer science, or a related fieldMinimum of 5 years of QA experience in clinical research, clinical systems, or regulated software environmentsStrong knowledge of GxP, ICH-GCP, 21 CFR Part 11, Annex 11, and SDLC principlesProven experience in conducting audits and managing CAPAsExcellent documentation and communication skillsPreferred: Experience in a company offering eClinical or biometric servicesPreferred: Familiarity with electronic QMS platforms such as ZenQMSBenefitsBenefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees.Choice of comprehensive Medical, Vision and Dental Insurance plansPaid vacation time and sick daysCorporate holidays annuallyParticipation in the 401K PlanComprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.Health Advocate and Employee Assistance ProgramLocationThis is a remote position, and we are open to candidates based in the United States.Equal Opportunity Employer Statement EDETEK is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Whenever possible, the company makes reasonable accommodations for qualified individuals with disabilities to the extent required by law.
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