QA Sr. Specialist - CAPA
$80,000–$95,000 year
On-siteShirley, New York, United States
Job Summary
Coordinate Corrective and Preventive Actions (CAPAs) and associated effectiveness checks in compliance with SOPs, internal policies, and cGMP requirements. Investigate, document, and manage timelines for CAPAs and effectiveness checks related to sterile pharmaceutical manufacturing. Facilitate meetings to drive aging CAPAs to completion and review Quality Systems data for trends. Support regulatory audit activities, customer SNCR processes, and internal or third-party inspections. Collaborate cross-functionally with QA staff, investigators, and leadership to maximize management control systems efficiency. Identify issues, evaluate metrics, and initiate resolution to ensure high-quality outputs. Complete monthly metrics and participate in continuous improvement initiatives to enhance the Quality System.
Required Qualifications
- Bachelor's degree in a science or engineering discipline
- 5+ years of Quality Assurance experience in a regulated environment
- Knowledge of applicable FDA regulations
- Experience in interpreting and applying FDA regulations to the organization
- Ability to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals
- Ability to effectively present information to top management, employees, or customers
- Demonstrated experience in CAPA writing, documenting issues, impact assessment, and risk management
- Understanding of how the pharmaceutical process pathway works, specifically how each of the various disciplines interact with each other
- Exceptional organizational and time management skills with the ability to effectively manage multiple tasks
- Detail-oriented with the ability to work independently and collaboratively in a team environment
Desired Qualifications
- Computer skills to include Microsoft Word, Excel, PowerPoint
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