Quality Assurance Analyst - QMS Specialist

About the role

The Quality Assurance Analyst (Senior QMS Specialist) owns Quality Management System processes for an assigned domain end to end, ensuring documentation, CAPA and audit activities meet ISO and regulatory expectations. Reporting to the Manager, Quality Management Systems (or an equivalent Quality/Compliance leader within Technology), the role manages the CAPA lifecycle, coordinates audit readiness and maintains document control standards, working independently on most assignments. It involves close collaboration with Technology process owners and Principal QMS colleagues.

Key responsibilities

• Own CAPA lifecycle management: investigation support, root-cause documentation review, effectiveness-check tracking and closure.
• Coordinate internal audit schedules and readiness, acting as point of contact for evidence collection and finding remediation.
• Review and approve controlled documentation (SOPs, work instructions) for accuracy, compliance and consistency with ISO and regulatory requirements.
• Manage change control records, ensuring risk assessment, approvals and implementation verification.
• Analyze quality metrics and trends (CAPA aging, finding recurrence, training compliance) and recommend process improvements.
• Support external audits and client or regulatory quality assessments, and mentor QMS Specialists on documentation standards, eQMS tooling and quality processes.
• Partner with process owners to embed quality-by-design practices, maintain eQMS configuration and workflows, and escalate systemic quality risks to the Manager.
• Support training-program administration and contribute to continuous improvement of the QMS.

Required profile

• Bachelor's degree in a related field or equivalent applied experience.
• 3-5 years of experience in quality management systems, quality assurance or regulatory compliance, ideally in technology, pharma or life sciences services.
• Demonstrated end-to-end experience managing CAPA, document control or change control.
• Preferred: experience coordinating internal or external audits, ASQ Certified Quality Auditor/Improvement Associate certification, GxP or ISO-certified environment experience, and familiarity with CSV/CSA concepts.

Required skills

• QMS processes: CAPA, change control, document control and audit management.
• eQMS platforms such as Veeva QMS, MasterControl, TrackWise, Qualio or ETQ Reliance, including workflow configuration and reporting.
• Solid understanding of ISO 9001 and/or ISO 27001 and regulatory frameworks (GxP, 21 CFR Part 11).
• Risk-assessment methods such as FMEA and analysis of quality data and metrics.