QA Specialist I – ACM

PCI Pharma Services; Madison (WI); On-site; USD 52,000 - 66,000; Full time

Job summary

PCI Pharma Services in Madison, Wisconsin is seeking a Quality Specialist I – ACM to monitor aseptic practices in ISO 5/ISO 6 environments, support aseptic integrity, product quality, and patient safety. You will observe operator behavior, document findings, escalate deviations, and collaborate across QA, Operations, Microbiology, and Training to drive continuous improvement.

A high school diploma is required; AS/BS life sciences preferred; 1–3 years QA/aseptic experience.

Qualifications

• High school diploma, GED, or equivalent; AS/BS preferred.
• 1–3 years QA, aseptic processing, or cleanroom in a cGMP environment.
• 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; capable of real-time coaching.
• Gowning for ISO 5/6/7 cleanrooms and remaining in those areas as needed.

Responsibilities

• Review operator aseptic behavior in ISO 5 areas and escalate concerns.
• Observe and document real-time manufacturing activities (setup, filling, EM, sanitization, interventions).
• Ensure compliance with aseptic technique, gowning standards, and cleanroom SOPs.
• Identify and escalate deviations posing contamination risk.
• Capture detailed records of events, interventions, and nonconformances using approved tools.
• Support media fill monitoring with visual monitoring and feedback throughout the process.
• Collaborate with QA, Operations, Microbiology, and Training to identify coaching and improvement opportunities.
• Participate in contamination control and environmental monitoring trending for site improvements.
• Assist investigations and root cause analyses for contamination events and EM excursions.

Skills

Quality Assurance

Aseptic techniques

Gowning

Documentation

Education

High school diploma or GED

AS/BS in Life Sciences

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’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.

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.