QA Specialist I - ACM

## QA Specialist I - ACMApplylocations:
Madison, WI, USAtime type:
Full time posted on:
Posted Todayjob requisition :
JR119010

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.
** 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.
*
* QUALIFICATIONS:

***
* Required:

*** 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.#LI-RS1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
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