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.
JOB DESCRIPTION:
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.
Skills Required
- High school Diploma, GED, or equivalent credential
- 1-3 years of experience in Quality Assurance, aseptic processing, or cleanroom functions
- Ability to learn aseptic techniques and cGMP regulations
- Excellent verbal and written communication skills
- Ability to gown for entry into cleanroom environments
- Proficient in Microsoft Office and electronic quality systems
- Prior experience in a QA or manufacturing oversight role
PCI Pharma Services Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about PCI Pharma Services and has not been reviewed or approved by PCI Pharma Services.
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Retirement Support — Feedback suggests the company provides a 401(k) with an employer match in the mid‑single‑digit range, with immediate vesting noted in certain cases. This is viewed as a solid component of the overall package.
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Leave & Time Off Breadth — PTO and paid holidays are commonly available, and some roles indicate vacation is accessible from early tenure. Availability of time off is frequently described as a positive element of the package.
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Affordable Benefits — Health insurance is sometimes described as reasonably priced depending on plan tier. Feedback suggests core medical, dental, and vision coverage is part of a standard offering.
PCI Pharma Services Insights
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
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