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 Responsibilities
1. Document & Process Auditing
- Conduct and/or host internal audits and vendor audits
- Review and audit Trial Master File (TMF) for completeness, accuracy, and compliance
- Track and report audit findings, deviations, and CAPAs (Corrective and Preventive Actions)
- Perform risk-based audit planning and inspection readiness assessments
2. SOPs, Policies and QMS Maintenance
- Review and assist in developing policies, SOPs, work practice documents, forms and other Quality Management System (QMS) documents
- Ensure alignment with the company’s Quality Policy and applicable external regulations
- Ensure controlled documents are reviewed periodically and in a timely manner
- Document and manage deviations, nonconformances, and CAPAs
- Maintain quality records and support archiving in accordance with regulatory timelines
3. Training Management
- Collaborate with functional managers to establish and periodically review training curricula, including study-specific training for internal teams
- Monitor overdue training, and follow up with individuals and their supervisors until completion
4. Computer System Validation Support
- Participate in validation planning and execution for internal and customer-facing systems
- Collaborate with software validation team and IT to review:
- Computer system validation plan (CVP)
- Functional/user requirements specifications and risk assessments
- Test scripts, validation protocols (IQ/OQ/PQ), and traceability matrices
- Test run reports and validations summary reports
- Review change requests, bug reports, and ensure re-validation as needed
- Ensure systems comply with 21 CFR Part 11 requirements, including audit trails, access control, and electronic signatures
5. Audit and Inspection Readiness
- Plan, 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 manner
- Audit trails and system logs are monitored and reviewed
- Access reviews, system related exercises and tests, and security scans are performed periodically
- Coordinate 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 deviations
- Lead 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 review
6. Cross-Functional Support
- Act 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 Improvement
- Lead 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.