QA Sr. Specialist - CAPA

Nature and Scope

The QA Senior Specialist - CAPA is responsible for ensuring that Corrective and Preventive Actions (CAPAs) and associated effectiveness checks are executed in compliance with company SOPs, internal policies, and applicable cGMP requirements. This role also supports the customer SNCR process, regulatory audit activities, and the Quality Council process. This is a cross-functional position that collaborates with all departments across American Regent.

Essential Duties and Responsibilities

• Coordinate specific departmental activities to maximize efficiency of management control systems, programs, policies, work methods and procedures.
• Interact and maintain relationships with colleagues, investigators, CAPA owners and staff to facilitate department objectives.
• Ensure Corrective/Preventative Actions and Effectiveness Checks are investigated, written and documented in accordance with SOPs, policies and cGMPs within assigned timelines.
• Ensure CAPA and Effectiveness timelines are maintained through inter-department communication with escalations as necessary.
• Facilitate meetings to drive aging CAPAs and Effectiveness Checks to completion.
• Review Quality Systems data and metrics for trends and report to QA Manager.
• Complete monthly metrics for CAPA and Effectiveness Checks.
• Support inspection readiness for regulatory inspections and internal or third-party audits.
• Provide support for customer Non-Compliance reports (SNCRs).
• Support Quality Council and Management Review meetings, including preparation and follow-up activities.
• Participate in cross-functional training with the QA Deviations team as needed.
• Participate in continuous improvement initiatives to enhance the Quality System.

Education Requirements and Qualifications

• Bachelor's degree in a science or engineering discipline, or 8 years' equivalent relevant experience in pharmaceutical quality assurance.
• 5+ years of Quality Assurance experience in a regulated environment, required.
• Knowledge of applicable FDA regulations and experience interpreting and applying them, required.
• Strong analytical, critical thinking, and problem-solving skills.
• Ability to effectively present information to top management, employees, or customers.
• Demonstrate experience in CAPA writing, documenting issues, impact assessment, and risk management.
• Understanding of the pharmaceutical process pathway and how disciplines interact.
• Exceptional organizational and time management skills.
• Detail-oriented with ability to work independently and collaboratively.
• Computer skills including Microsoft Word, Excel, PowerPoint, preferred.