QA Sr. Specialist - CAPA

QA Sr. Specialist - CAPA

Overview

The QA Senior Specialist - CAPA is responsible for ensuring that Corrective and Preventive Actions (CAPAs) and related effectiveness checks are executed in compliance with company SOPs, internal policies, and applicable cGMP requirements. This role supports the customer SNCR process, regulatory audit activities, and the Quality Council process. It is a cross-functional position that collaborates with all departments across American Regent, located in Shirley, NY. The incumbent participates in planning, implementing, and maintaining quality systems to meet or exceed the company’s quality standards and regulatory expectations.

Responsibilities

• Coordinate departmental activities to maximize the efficiency of management control systems, programs, policies, work methods, and procedures.
• Collaborate with QA staff, colleagues, and leadership to ensure goals and objectives are achieved in a timely manner.
• Interact with colleagues, investigators, CAPA owners, and staff to facilitate department objectives and maintain positive working relationships.
• Provide detailed support for QA activities and communicate interrelated activities with other programs, departments, or staff within appropriate timeframes.
• Work independently with minimal supervision to deliver timely results while effectively managing multiple tasks.
• Ensure CAPAs and Effectiveness Checks related to the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated, written, and documented in accordance with company SOPs, policies, and cGMPs within assigned timelines.
• Identify issues, evaluate metrics, and support internal audits under the direction of the QA Supervisor.
• Maintain CAPA and Effectiveness timelines 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 within the assigned area of support and report to the QA Manager.
• Ensure completeness, accuracy, and consistency of work to meet quality standards; identify and resolve errors and inconsistencies to maintain high quality.
• Complete monthly metrics for CAPA and Effectiveness Checks.
• Provide additional Quality System support, including inspection readiness for regulatory inspections and internal or third-party audits.
• Support customer Non-Compliance Reports (SNCRs) and participate in Quality Council and Management Review activities, including preparation and follow-up.
• Participate in cross-functional training with the QA Deviations team as needed and contribute to continuous improvement initiatives to enhance the Quality System.
• Represent the QA group in continuous improvement committees or working groups.
• Perform other tasks and duties as assigned by management.

Requirements

• Bachelor’s degree in a science or engineering discipline.
• 5+ years of Quality Assurance experience in a regulated environment.
• Knowledge of applicable FDA regulations and experience interpreting and applying them to the organization.
• Strong analytical, critical thinking, and problem-solving skills.
• Ability to read Standard English documents such as SOPs, maintenance schedules, and operating manuals; ability to effectively present information to management, employees, or customers.
• Demonstrated experience in CAPA writing, documenting issues, impact assessment, and risk management.
• Understanding of pharmaceutical process pathways and how various disciplines interact with each other.
• Exceptional organizational and time management skills with the ability to manage multiple tasks.
• Detail-oriented with the ability to work independently and collaboratively in a team.
• Computer skills including Microsoft Word, Excel, and PowerPoint (preferred).
• Location: Shirley, NY.