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PCI
Madison, WI, USA; USA_WI_Madison
Source: PCI careers · View original posting
From PCI's posting. “We” and “our” refer to the employer.
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.
SECOND SHIFT
The Quality Associate I - Operations is the first of two levels within the QA Associate job family The associate I provides real-time QA support on the floor for GMP Manufacturing of drug product. The work scope includes floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed. Real time continuous monitoring of manufacturing related systems and processes to ensure compliance with applicable regulatory
and industry standards, needed quality improvements, and safety/efficacy for phase appropriate GMP manufacture of drug products
Perform QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing
May participate in root cause analysis using methodologies, such as: fishbone, 5 whys, etc.
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