Control Analyst

Position Summary

The Change Control Analyst administers and manages the Change Control process within the electronic Quality Management System (eQMS), ensuring changes are assessed, evaluated, approved, implemented, and closed in compliance with regulatory requirements and company procedures.

• Administer and maintain the Change Control system within the eQMS.
• Coordinate the change control lifecycle from initiation through effectiveness verification and closure.
• Review submissions for completeness, accuracy, and adherence to procedures.
• Facilitate impact assessments with SMEs and cross-functional stakeholders (regulatory, quality, validation, training, manufacturing, laboratory, business).
• Monitor progress, follow up with record owners, and ensure timely deliverables.
• Support CCB (or equivalent) meetings (agenda, presentations, decision tracking, action documentation).
• Verify linked and completed supporting documentation prior to closure (validation, risk assessments, training, CAPAs, document revisions, regulatory filings).
• Generate and analyze change management metrics (cycle times, aging, overdue tasks, throughput, closure trends).
• Prepare materials for internal/external audits and regulatory inspections.
• Investigate process delays and drive improvements.
• Provide guidance/training on change control procedures and regulatory expectations.
• Collaborate with QA, Regulatory Affairs, Manufacturing, Laboratory Operations, IT, and others.
• Maintain electronic/physical records per retention requirements.

• 1–3 years in Quality Systems, Change Control, Quality Assurance, Document Control, Regulatory Affairs, Manufacturing, or related regulated environment.
• BS/BA in Life Sciences, Quality, Engineering, or related; equivalent experience considered.
• eQMS experience.
• Knowledge of quality system principles and change management.
• Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Strong organization; excellent written/verbal communication; attention to detail.

• eQMS tools (Dot Compliance, Master Control, Veeva, Track Wise, or equivalent).
• Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485/15189, CAP/CLIA/EU IVDR/MDSAP.
• Risk and impact assessment experience.
• Validation/qualification, software lifecycle, training management knowledge.
• Regulatory inspection and quality audit experience.
• Analytical skills for metrics/trends; interpret regulations/standards; continuous improvement.

• May lift up to 30 pounds; desk work with occasional exposure to data center noise, fumes, and bio-hazardous materials.

• Job-specific, safety, and compliance training assigned based on role.

• May work weekends/holidays.