Aseptic QA Specialist I — Real-Time Compliance

PCI Pharma Services; Madison (WI); On-site; USD 52,000 - 76,000; Full time

Job summary

PCI Pharma Services in Madison, WI is hiring a Quality Specialist I – ACM to monitor aseptic behaviors in ISO 5/ISO 6 environments. You will document events, support media fills, and collaborate with QA, Operations and Training to drive continuous improvement.

The role requires learning aseptic techniques, cGMP regulations, and gowning for long stays in cleanrooms, with strong communication and accurate observation as key assets.

Qualifications

• Experience in Quality Assurance or aseptic processing in a cGMP environment.
• Ability to learn aseptic techniques 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 skills; must be comfortable providing real-time coaching.
• Ability to gown for entry into ISO 5, 6 and 7 cleanroom environments and remain in those areas for extended periods.

Responsibilities

• Review operator’s aseptic behavior within the ISO 5 core and adjacent classified areas and accelerate any concerns to the operator or their supervisor.
• Observe and document real-time activities during manufacturing operations, including setup, filling, environmental monitoring, sanitization and routine/corrective interventions.
• Ensure compliance with PCI aseptic technique expectations, gowning standards, and cleanroom behavior as outlined in SOPs and training.
• Identify and elevate deviations from aseptic practices, personnel behaviors, or environmental controls that pose potential contamination risks.
• Capture detailed and objective records of events, interventions, and nonconformances using PCI-approved documentation tools or checklists.
• Support media fill (aseptic process simulation) operations by providing visual monitoring and feedback throughout the process.
• Collaborate with Quality Assurance, Operations, Microbiology, and Training to identify opportunities for coaching, retraining, and continuous improvement.
• Participate in contamination control and environmental monitoring trending to drive site-level improvements and reduce contamination risk.
• Assist with investigations and root cause analysis for contamination events, EM excursions, and aseptic technique deviations.

Skills

Critical observation

Documentation

Coaching

Verbal communication

Cleanroom gowning

Education

High school diploma

AS degree in Life Sciences

BS degree in Life Sciences

Tools

Microsoft Office

Electronic quality systems

Job description

PCI Pharma Services in Madison, WI is hiring a Quality Specialist I – ACM to monitor aseptic behaviors in ISO 5/ISO 6 environments. You will document events, support media fills, and collaborate with QA, Operations and Training to drive continuous improvement.

The role requires learning aseptic techniques, cGMP regulations, and gowning for long stays in cleanrooms, with strong communication and accurate observation as key assets.