Real-Time Aseptic QA Specialist I

PCI Pharma Services; Madison (WI); On-site; USD 52,000 - 66,000; Full time

Job summary

PCI Pharma Services in Madison, Wisconsin is seeking a Quality Specialist I – ACM to monitor aseptic practices in ISO 5/ISO 6 environments, support aseptic integrity, product quality, and patient safety. You will observe operator behavior, document findings, escalate deviations, and collaborate across QA, Operations, Microbiology, and Training to drive continuous improvement.

A high school diploma is required; AS/BS life sciences preferred; 1–3 years QA/aseptic experience.

Qualifications

• High school diploma, GED, or equivalent; AS/BS preferred.
• 1–3 years QA, aseptic processing, or cleanroom in a cGMP environment.
• Ability to learn aseptic techniques, contamination control, and cGMP regulations (21 CFR Parts 210/211, EU Annex 1).
• Demonstrated ability to observe critically and document behaviors accurately and objectively.
• Excellent verbal and written communication; capable of real-time coaching.
• Gowning for ISO 5/6/7 cleanrooms and remaining in those areas as needed.

Responsibilities

• Review operator aseptic behavior in ISO 5 areas and escalate concerns.
• Observe and document real-time manufacturing activities (setup, filling, EM, sanitization, interventions).
• Ensure compliance with aseptic technique, gowning standards, and cleanroom SOPs.
• Identify and escalate deviations posing contamination risk.
• Capture detailed records of events, interventions, and nonconformances using approved tools.
• Support media fill monitoring with visual monitoring and feedback throughout the process.
• Collaborate with QA, Operations, Microbiology, and Training to identify coaching and improvement opportunities.
• Participate in contamination control and environmental monitoring trending for site improvements.
• Assist investigations and root cause analyses for contamination events and EM excursions.

Skills

Quality Assurance

Aseptic techniques

Gowning

Documentation

Education

High school diploma or GED

AS/BS in Life Sciences

Tools

Microsoft Office

Electronic quality systems

Job description

PCI Pharma Services in Madison, Wisconsin is seeking a Quality Specialist I – ACM to monitor aseptic practices in ISO 5/ISO 6 environments, support aseptic integrity, product quality, and patient safety. You will observe operator behavior, document findings, escalate deviations, and collaborate across QA, Operations, Microbiology, and Training to drive continuous improvement.

A high school diploma is required; AS/BS life sciences preferred; 1–3 years QA/aseptic experience.