QA Specialist I - ACM 2nd Shift
Core
Real-time monitoring of aseptic behaviors during sterile manufacturing in ISO 5/6 environments to ensure product quality and patient safety.
Role type
Quality Specialist I (Aseptic Manufacturing)
Builds
Sterile manufacturing processes for biopharma clients
Domain
Biopharma / Aseptic Manufacturing / cGMP
Required skills
Aseptic technique observation, Cleanroom gowning (ISO 5/6/7), cGMP compliance (21 CFR 210/211, EU Annex 1), Contamination control, Root cause analysis, Documentation of deviations, Environmental monitoring trending
Preferred skills
Electronic quality systems proficiency, Microsoft Office, Prior PCI or similar aseptic operation experience
Technologies
Electronic quality systems, Microsoft Office
Responsibilities
Review operator aseptic behavior and escalate concerns, Observe and document real-time manufacturing activities, Ensure compliance with gowning standards and SOPs, Identify and escalate contamination risks, Capture records of events and nonconformances, Support media fill operations with visual monitoring, Collaborate on coaching and continuous improvement, Assist with investigations for contamination events
Seniority
Entry-level to Mid-level, hands-on IC