Aseptic QA Specialist I - Drive Cleanroom Quality

PCI TRGR Penn Pharmaceutical Services Ltd; Madison (WI); On-site; USD 52,000 - 76,000; Full time

Job summary

PCI Pharma Services in Madison, Wisconsin is seeking a Quality Specialist I – ACM to support aseptic operations within ISO 5 environments. You will review operator behaviors, document events, and ensure adherence to gowning standards and cleanroom practices.

This role emphasizes real-time coaching, deviation escalation, and collaboration with QA, Operations, Microbiology and Training to drive contamination control and continuous improvement in a cGMP setting.

Qualifications

• High school diploma or GED required; AS/BS Life Sciences preferred.
• 1–3 years in QA, aseptic processing, or cleanroom in a cGMP environment.
• Ability to learn aseptic techniques, contamination control, and 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; comfortable providing real-time coaching.

Responsibilities

• Review operator’s aseptic behavior within ISO 5 core and adjacent areas and escalate concerns.
• Observe and document real-time activities during manufacturing operations, including setup, filling, environmental monitoring, sanitization and routine/corrective interventions.
• Ensure compliance with 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 contamination risks.
• Capture detailed records of events, interventions, and nonconformances using PCI documentation tools or checklists.
• Support media fill (aseptic process simulation) operations by providing visual monitoring and feedback.
• Collaborate with Quality Assurance, Operations, Microbiology, and Training to identify coaching and continuous improvement opportunities.

Skills

Aseptic processing

Cleanroom

Quality Assurance

Gowning

cGMP

Microsoft Office

Electronic quality systems

Communication

Documentation

Education

HS Diploma/GED

AS/BS Life Sciences

Tools

Microsoft Office

Electronic quality systems

Job description

PCI Pharma Services in Madison, Wisconsin is seeking a Quality Specialist I – ACM to support aseptic operations within ISO 5 environments. You will review operator behaviors, document events, and ensure adherence to gowning standards and cleanroom practices.

This role emphasizes real-time coaching, deviation escalation, and collaboration with QA, Operations, Microbiology and Training to drive contamination control and continuous improvement in a cGMP setting.