Senior QA Specialist, Change Management

The Position (Senior QA Specialist, Quality Assurance)
Responsibilities

• Support QMS change control system components (review, process, and disposition change requests for completeness, accuracy, and procedural compliance).
• Coordinate and support Change Control Board (CCB) meetings (agenda, minutes, and follow-up to closure).
• Support cross-functional impact assessments; confirm action plans and effectiveness checks.
• Partner in risk assessment activities to identify, evaluate, and document quality/compliance risks.
• Maintain and update CCB schedules and dashboards.
• Perform quality review and disposition of change controls/effectiveness checks for accuracy, completeness, and regulatory alignment prior to approval escalation.
• Compile metrics and prepare reports for review boards and annual product quality reviews.
• Train and coach stakeholders on QMS change management processes.
• Support internal audits, regulatory inspections, and third-party audits as a subject matter resource.
• Drive continuous improvement of QMS change management processes and workflows.
• Write/review/change control/issue/organize procedural documents (policies, SOPs, work instructions, forms) using existing templates.
• Additional duties as assigned.

• Bachelor’s degree in a science discipline (or equivalent).
• 5+ years in a regulated environment; preference for QA, change management, and/or risk management.
• Working knowledge of FDA, EU, and ICH GxP regulations and guidance.
• Excellent written/verbal communication; effective with internal/external parties.
• Ability to coordinate cross-functional activities and drive tasks to completion.
• Proficiency with Microsoft Word, Excel, and Smartsheet.

• Independent work; manage priorities in a fast-paced environment.
• Experience with GMP-supporting quality systems (21 CFR Parts 11, 210, 211, QMSR, EU GMP).
• Prior use of an electronic document and quality management system in a regulated environment.

Wisconsin pay range: $90,000–$110,000.

Candidates must have current, valid authorization to work in the country where this role is located.