QA Specialist I - ACM 2nd Shift

PCI Pharma Services seeks a Quality Specialist I for second-shift aseptic monitoring in Madison, Wisconsin. The role involves real-time observation of sterile manufacturing operations, documentation of compliance with cleanroom standards, and support for contamination control initiatives in ISO 5 and ISO 6 environments.

Responsibilities

• Monitor operator aseptic behavior in ISO 5 core and adjacent classified areas; escalate concerns
• Observe and document real-time manufacturing activities including setup, filling, sanitization, and interventions
• Verify compliance with aseptic technique expectations, gowning standards, and cleanroom SOPs
• Identify and escalate deviations, contamination risks, and environmental control excursions
• Support media fill operations and assist with contamination investigations and root cause analysis

Requirements

• High school diploma, GED, or equivalent; AS/BS in life sciences preferred
• 1–3 years quality assurance, aseptic processing, or cleanroom experience in cGMP environment
• Knowledge of aseptic techniques, contamination control, and cGMP regulations (21 CFR Parts 210/211, EU Annex 1)
• Ability to observe critically and document behaviors objectively and accurately
• Strong verbal and written communication skills with real-time coaching capability
• Capability to gown and work in ISO 5, 6, and 7 cleanrooms for extended periods
• Proficiency in Microsoft Office and electronic quality systems preferred