Hiring: QA Specialist I - ACM Company: PCI Pharma Services Location: Madison, WI Job Posted Time: 2026-09-16 13:51:57 Target Skills & Keywords : Microsoft Office, Quality Assurance, Root Cause Analysis About the job Experience: •1-3 years of experience in Quality Assurance, aseptic processing, or cleanroom functions within a cGMP‑regulated environment; equivalent combination of education and experience will be considered •3 years of experience in Quality Assurance, aseptic processing, or cleanroom functions within a cGMP‑regulated environment; equivalent combination of education and experience will be considered Required Skills: •Review operator’s aseptic behavior within the ISO 5 core and adjacent classified areas and escalate 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 escalate 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. •Partner cross-functionally 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. Qualifications: •High school Diploma, GED, or equivalent credential required, AS degree or BS degree in Life Sciences or related field preferred. •Demonstrated capacity 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; must be comfortable providing real-time coaching. •Demonstrated capacity to gown for entry into ISO 5, 6 and 7 cleanroom environments and remain in those areas for extended periods. •Proficient in Microsoft Office and electronic quality systems (preferred). •Prior experience in a QA or manufacturing oversight role at PCI or a similar aseptic operation is strongly preferred. •Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future •Equal Employment Opportunity (EEO) Statement Compensation: •At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!