QA Specialist I - ACM

PCI Pharma Services • Madison, WI

7d • Onsite

About The Position

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.

Requirements

• High school Diploma, GED, or equivalent credential required
• 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.

Nice To Haves

• AS degree or BS degree in Life Sciences or related field 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.

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.

Benefits

• 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.
• At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience.
• Our people make all of this happen, so providing an industry leading experience for our people is equally as important.
• By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers.
• We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program.
• We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED