QA Specialist I - ACM
On-siteMadison, Wisconsin, United States
Job Summary
Monitor aseptic behaviors during sterile manufacturing, including gowning, interventions, environmental monitoring, and material handling in ISO 5/ISO 6 environments. Review operator activities within the ISO 5 core and adjacent areas, documenting real-time events, setups, and sanitization while escalating deviations that pose contamination risks. Capture objective records of nonconformances using approved tools and support media fill operations with visual monitoring and feedback. Collaborate with Quality Assurance, Operations, Microbiology, and Training to coach personnel, analyze root causes for contamination events, and drive site-level improvements through environmental monitoring trending.
Required Qualifications
- High school Diploma, GED, or equivalent credential
- 1-3 years of experience in Quality Assurance, aseptic processing, or cleanroom functions within a cGMP-regulated 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 skills
- Ability to gown for entry into ISO 5, 6 and 7 cleanroom environments and remain in those areas for extended periods
Desired Qualifications
- AS degree or BS degree in Life Sciences or related field
- Proficient in Microsoft Office and electronic quality systems
- Prior experience in a QA or manufacturing oversight role at PCI or a similar aseptic operation
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