Job Description
Job Description
???? Temporary QA Support – Wilmington, MA
Eckert & Ziegler Radiopharma, Inc. (EZRI) is seeking a temporary QA Specialist to support site Quality Assurance operations during an employee leave period.
This is a 4-month, on-site contract role within a regulated cGMP sterile manufacturing environment. The selected candidate will provide hands-on QA support to ensure continuity of batch review, documentation control, and GMP compliance across isotope manufacturing and CMO activities.
Position Overview
The QA Specialist will step into an active production environment and support daily Quality operations, maintaining compliance standards and documentation discipline.
This role requires strong cGMP knowledge, attention to detail, and the ability to operate independently.
Key Responsibilities
• Perform batch record review and release documentation support
• Support deviation investigations and CAPA documentation
• Review and approve GMP documentation (SOPs, change controls, protocols)
• Provide floor-based QA presence during manufacturing operations
• Ensure compliance with FDA cGMP regulations
• Maintain audit-ready documentation and records
• Support internal quality processes as needed during leave coverage
Qualifications
• 3–7+ years of QA experience in pharmaceutical or biopharmaceutical manufacturing
• Experience in cGMP-regulated environments required
• Experience in sterile or cleanroom manufacturing strongly preferred
• Strong documentation review and technical writing skills
• Ability to step into an active GMP environment with minimal ramp-up
• Radiopharmaceutical experience a plus
Work Structure
• On-site in Wilmington, MA
• 4-month temporary contract (leave coverage)
• Full-time hours: Monday–Friday, 8:00 AM – 4:30 PM
• Immediate availability preferred
Why Join EZRI?
• Contribute to a mission-driven organization advancing nuclear medicine
• Work in a collaborative, execution-focused GMP environment
• Provide critical support ensuring uninterrupted manufacturing operations
If you are an experienced QA professional available for short-term assignment and comfortable operating in a sterile manufacturing environment, we welcome the opportunity to connect.