QA Sr. Specialist - CAPA

American Regent, Inc.•Shirley, NY

3d•$80,000 - $95,000

About The Position

The QA Senior Specialist - CAPA ensures Corrective and Preventive Actions (CAPAs) and associated effectiveness checks are completed in compliance with company SOPs, internal policies, and applicable cGMP requirements. The role also supports the customer SNCR process, regulatory audit activities, and the Quality Council process. It is a cross-functional position working with departments across American Regent and participates in planning, implementing, and maintaining quality systems that meet or exceed company quality standards and regulatory expectations. The position independently manages and documents CAPAs and effectiveness checks related to the manufacture of safe, pure, and effective sterile pharmaceuticals. It monitors timelines and metrics, coordinates across departments, facilitates meetings to complete aging items, and reports trends to QA management. Additional support includes inspection readiness, customer non-compliance reports, Quality Council and Management Review activities, cross-functional training, and continuous improvement initiatives.

Requirements

Bachelor’s degree in a science or engineering discipline, or 8 years of equivalent relevant experience in pharmaceutical quality assurance demonstrating the knowledge and skills necessary for the role.
At least 5 years of Quality Assurance experience in a regulated environment.
Knowledge of applicable FDA regulations and experience interpreting and applying them to an organization.
Strong analytical, critical-thinking, and problem-solving skills.
Ability to read Standard English documents, including Standard Operating Procedures, maintenance schedules, and operating manuals.
Ability to effectively present information to top management, employees, or customers.
Experience in CAPA writing, documenting issues, impact assessment, and risk management.
Understanding of pharmaceutical process pathways and how the various disciplines interact.
Strong organizational and time-management skills, including the ability to manage multiple tasks.
Detail-oriented, with the ability to work independently and collaboratively in a team environment.

Nice To Haves

Computer skills, including Microsoft Word, Excel, and PowerPoint.

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 accomplish goals and objectives in a timely manner.
Maintain working relationships with colleagues, investigators, CAPA owners, and staff to facilitate department objectives.
Support the QA Department and coordinate interrelated activities with other programs, departments, or staff, communicating within appropriate timeframes.
Work independently with minimal supervision, manage multiple tasks, and deliver timely results.
Investigate, write, and document Corrective and Preventive Actions and associated effectiveness checks in accordance with company SOPs, policies, cGMPs, and assigned timelines.
Identify issues, evaluate metrics, and support internal audits under the direction of the QA Supervisor.
Maintain CAPA and effectiveness-check timelines through interdepartmental communication and escalate as necessary.
Facilitate meetings to drive aging CAPAs and effectiveness checks to completion.
Review Quality Systems data and metrics for trends in the assigned area and report findings to the QA Manager.
Confirm work is complete, accurate, consistent, and meets quality standards; identify errors and inconsistencies and initiate resolution.
Complete monthly metrics for CAPAs 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 and identify continuous improvement initiatives for the Quality System.
Represent the QA group in continuous improvement committees or working groups.
Perform other tasks and duties as assigned by management.