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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.

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.