Overview
Quality Assurance Specialist Jobs in New York, United States at United Pharma
Title: Quality Assurance Specialist
Company: United Pharma
Location: New York, United States
🚨 Hiring: Quality Assurance Specialist
We are actively seeking a Quality Assurance Specialist to join a regulated pharmaceutical/biotech manufacturing environment. This opportunity is ideal for professionals with a strong background in GMP compliance, quality systems, documentation management, and regulatory support.
Key Responsibilities:
✔ Support Quality Management System (QMS) activities
✔ Review and approve GMP documentation, SOPs, and batch records
✔ Manage deviations, CAPAs, change controls, and investigations
✔ Support internal and external audits
✔ Ensure compliance with FDA, GMP, and regulatory requirements
✔ Collaborate with cross-functional teams to drive quality initiatives
✔ Assist with validation, compliance, and quality improvement projects
Qualifications:
▪ 3+ years of Quality Assurance experience in pharmaceutical, biotech, medical device, or regulated manufacturing environments
▪ Strong understanding of GMP regulations and quality systems
▪ Experience with deviations, CAPAs, change controls, and audits
▪ Excellent documentation and communication skills
▪ Ability to work in a fast-paced and compliance-driven environment
