QA Specialist I - ACM

PCI Pharma Services; Madison (WI); On-site; USD 45,000 - 65,000; Full time

Job summary

A leading biopharma services provider located in Madison, Wisconsin, seeks a Quality Specialist I - Aseptic Core Monitor to ensure compliance with aseptic operations and regulatory expectations. This role involves real-time oversight during sterile manufacturing processes and collaboration with various teams to enhance quality standards. Candidates should have a high school diploma and relevant experience in sterile environments. Join a mission-driven team focused on delivering life-changing therapies while upholding the highest quality and safety standards.

Qualifications

• 1-2 years' experience in sterile pharmaceutical manufacturing or aseptic processing.
• Ability to learn and apply aseptic techniques and cGMP regulations.
• Excellent verbal and written communication skills.

Responsibilities

• Provide continuous oversight of aseptic behaviors during manufacturing.
• Document real-time activities and deviations from aseptic practices.
• Collaborate with various departments for process improvement.

Skills

Aseptic techniques

Contamination control

cGMP regulations

Real-time coaching

Observation and documentation

Education

High School Diploma or GED

Associate's or Bachelor's degree 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.

The Quality Specialist I - Aseptic Core Monitor (ACM) at PCI Pharma Services is a critical member of the aseptic operations team responsible for ensuring that all activities within the aseptic core align with regulatory expectations, PCI procedures, and industry best practices. The Quality Specialist I - ACM provides real-time oversight 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:

• Provide continuous oversight of operator performance and aseptic behavior inside the ISO 5 core and adjacent classified areas.
• 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 or GED required, Associate's or Bachelor's degree in Life Sciences / related field or experience in leadership role preferred.
• Minimum 1-2 years' experience in sterile pharmaceutical manufacturing, aseptic processing, or cleanroom oversight.
• 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.