QA Specialist I - ACM 2nd Shift

PCI TRGR Penn Pharmaceutical Services Ltd; Madison (WI); On-site; USD 60,000 - 86,000; Full time

Job summary

PCI Pharma Services is seeking a Quality Specialist I – ACM in Madison, WI to monitor aseptic behaviors in ISO 5/ISO 6 cleanrooms, document activities, and support contamination control. The role ensures aseptic integrity, product quality, and patient safety through real-time coaching and precise record-keeping.

Responsibilities include observing operations, ensuring gowning compliance, and collaborating across QA, Operations, Microbiology and Training to drive continuous improvements and

Qualifications

• 1-3 years of experience in Quality Assurance, aseptic processing, or cleanroom functions within a cGMP-regulated environment.
• Ability to learn aseptic techniques, contamination control, and 21 CFR Parts 210/211.
• Demonstrated observation and documentation of behaviors accurately and objectively.
• Excellent verbal and written communication skills; comfortable providing real time coaching.

Responsibilities

• Review operator aseptic behavior within the ISO 5 core and adjacent areas and elevate concerns to the operator or supervisor.
• Observe and document real-time activities during manufacturing operations, including setup, filling, environmental monitoring, sanitization and interventions.
• Ensure compliance with aseptic technique expectations, gowning standards, and cleanroom behavior per SOPs.
• Identify and elevate deviations that pose contamination risks.
• Document events, interventions, and nonconformances using PCI tools or checklists.
• Support media fill operations with visual monitoring and feedback.
• Collaborate with QA, Operations, Microbiology, and Training for coaching and continuous improvement.
• Participate in contamination control and environmental monitoring trending.
• Assist with investigations and root cause analysis for contamination events.

Skills

Verbal communication

Written communication

Observation skills

Real-time coaching

Critical thinking

Education

High school diploma or GED

AS degree in Life Sciences or related field

BS degree in Life Sciences or related field

Tools

Microsoft Office

Electronic quality systems

Job description

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 aseptic behavior within the ISO 5 core and adjacent classified areas, and elevate 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 elevate 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

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.

Why work for PCI Pharma Services?

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.