High school Diploma, GED, or equivalent credential required, AS degree or BS degree in Life Sciences or related field preferred.
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
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; 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.
Preferred:
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.
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Benefits
Vision insuranceEquity / stock options
Additional Information
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
JOB DESCRIPTION:
Position Title : Quality Specialist I - ACM
Location: Madison, Wisconsin
Department: Quality Assurance
Reporting To: Supervisor, Quality Assurance Internal Operations
Responsible For (Staff): No
The Quality Specialist I - ACM provides real-time monitoring of aseptic behaviors during sterile manufacturing, including gowning, interventions, environmental monitoring, and material handling in ISO 5/ISO 6 environments. This role supports PCI's mission of maintaining a high standard of aseptic integrity, product quality, and patient safety.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
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.
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.
Pciservices · Madison, WI