Job description

Quality Assurance Associate — 503B Outsourcing Facility (New York, NY)

Galaxypharma is hiring a Quality Assurance Associate to be part of the quality function at our New York-based 503B outsourcing facility.

About the Role

You'll be part of Galaxypharma's Quality Management System (QMS), ensuring full compliance with cGMP (21 CFR Parts 210/211), FDA 503B outsourcing facility requirements, and USP <795>/<797> sterile compounding standards.

What You'll Do

Author, review, and continuously improve the site Quality Management System, including document control, deviations, CAPA, and change control programs etc.
Support the team during preparation for FDA inspections and other regulatory audits; own audit and 483 response and CAPA commitments
Review SOPs and controlled documents; ensure the document control program keeps pace with regulatory and operational change
Support the environmental monitoring program and ensure timely investigation of excursions
Partner cross-functionally with Production, Regulatory Affairs, and Compounding leadership to ensure compliance is built into operations, not bolted on
Track quality metrics and report on QMS health to site leadership

What You'll Bring

Bachelor's degree in Chemistry, Biology, Pharmacy, Microbiology, or related field
2+ years of QA experience in a pharmaceutical, 503B/503A, nuclear or sterile manufacturing environment, including 2+ years in a supervisory/leadership capacity
Strong working knowledge of cGMP, FDA 503B requirements, USP <797>, and data integrity (ALCOA+) principles
Demonstrated experience leading FDA inspections and regulatory audits
Proven track record building and improving quality systems, SOPs, and CAPA programs
Strong leadership, cross-functional communication, and decision-making skills
ASQ CQA/CQE or Lean Six Sigma certification a plus

Location: Albany, NY (on-site — cleanroom/cGMP floor presence required)

Employment Type: Full-Time

Pay: From $70,000.00 per year

Work Location: In person