Aseptic QA Monitor I - Real-Time Cleanroom Observer

PCI Pharma Services

Madison (WI)

On-site

USD 55,000 - 75,000

Full time

8 days ago

Application generator

Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

PCI Pharma Services in Madison, Wisconsin is seeking a Quality Specialist I - ACM to monitor aseptic behaviors in ISO 5/ISO 6 environments and support real-time quality assurance. You will observe manufacturing operations, document events and deviations, and collaborate with QA, Operations, Microbiology, and Training to drive continuous improvement and product quality and patient safety.

Qualifications include a high school diploma or equivalent and 1–3 years in QA/aseptic processing; AS/BS

Qualifications

High school diploma or equivalent required; AS/BS in Life Sciences preferred.
Ability to learn aseptic techniques, contamination control, and cGMP regulations (21 CFR Parts 210/211).
Strong observation and objective documentation skills; excellent verbal and written communication.

Responsibilities

Review operator aseptic behavior in ISO 5 core areas and elevate concerns.
Observe and document real-time manufacturing activities (setup, filling, environmental monitoring, sanitization).
Ensure compliance with aseptic technique expectations and gowning standards.
Identify and elevate deviations that pose contamination risks.
Record events, interventions, and nonconformances accurately using approved tools.
Support media fill operations with visual monitoring and feedback.
Collaborate with QA, Operations, Microbiology, and Training for coaching and improvements.
Assist investigations and root cause analyses for contamination events and EM excursions.