QA Associate I
1 week ago
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.Step Into Quality. Start Your Career with Purpose.Are you eager to build your career in pharmaceutical manufacturing while making a meaningful impact on product quality and patient safety? Join us at PCI as a Quality Associate I – Operations, where you’ll be on the front lines of GMP production—supporting real-time quality oversight, solving problems as they arise, and ensuring that every product meets the highest standards of safety, efficacy, and compliance.This is an ideal role for early-career professionals passionate about science, quality, and continuous improvement. You'll receive hands-on training, mentorship, and exposure to industry best practices while working in a fast-paced, collaborative environment.What You'll DoProvide real-time QA support on the production floor: observe critical operations, audit procedures, and monitor compliance during GMP manufacturingPerform in-process reviews of executed batch records and documentation for completeness and accuracyParticipate in lot disposition and review of drug product and intermediatesAct as a first responder to quality issues, documenting investigations and supporting immediate corrective actionsConduct Acceptable Quality Limit (AQL) visual inspections of drug productSupport deviation documentation, root cause investigations (using tools like 5 Whys, Fishbone), and CAPA processesCollaborate across departments and represent QA during manufacturing activities and process improvementsContribute to SOP revisions, quality initiatives, and regulatory readinessWhat You BringBachelor’s degree in a relevant scientific field (preferred)0–2 years of experience in the pharmaceutical or biotech industry1+ years of experience in QA Operations (preferred)Understanding of GMP regulations (21 CFR 210/211/820); exposure to ICH guidelines and risk tools (FMEA, HACCP, ICH Q9) a plusStrong organizational and technical writing skills, with attention to detailFamiliarity with Microsoft Word, Excel, and OutlookAbility to manage multiple tasks and communicate effectively across teamsSelf-starter mindset with the ability to work independently and escalate issues appropriatelyFlexible and adaptable to fast-paced, evolving environmentsPreferred but Not RequiredASQ certificationExposure to Lean/Operational Excellence methodologiesExperience supporting commercial or late-stage clinical GMP operations#LI-LL1Join us and be part of building the bridge between life changing therapies and patients.
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QA Associate I
3 weeks ago
Madison, United States PCI Pharma Services Full timeQuality Associate I Operations 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. Step Into Quality....
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QA Associate I
1 day ago
Madison, Wisconsin, United States PCI Pharma Services Full timeLife 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.Step Into Quality. Start Your Career with...
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QA Associate I
2 weeks ago
Madison, WI, United States PCI Pharma Services Full timeLife 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. Step Into Quality. Start Your Career with...
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CGMP QA Document Control Specialist I
2 weeks ago
Madison, United States PCI Pharma Services Full timeA pharmaceutical services provider in Madison, Wisconsin, is seeking a QA Specialist I - Doc Control to manage CGMP documentation and maintain quality systems. Candidates should possess exceptional organizational skills, prior GMP experience, and a relevant degree. Join the team focusing on impactful therapies and patient care. Training and collaboration...
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QA Specialist I Quality Assurance
2 weeks ago
Madison, United States PCI TRGR Penn Pharmaceutical Services Ltd Full timeA leading pharmaceutical services provider in Madison, WI is seeking a QA Specialist I to ensure product quality and compliance with internal procedures and external standards. The role involves batch record review, deviation evaluation, and quality oversight. Candidates should have a Bachelor's degree and relevant industry experience. This position offers...
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CGMP QA Document Control Specialist I
2 weeks ago
Madison, WI, United States PCI Pharma Services Full timeA pharmaceutical services provider in Madison, Wisconsin, is seeking a QA Specialist I - Doc Control to manage CGMP documentation and maintain quality systems. Candidates should possess exceptional organizational skills, prior GMP experience, and a relevant degree. Join the team focusing on impactful therapies and patient care. Training and collaboration...
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CGMP QA Document Control Specialist I
2 weeks ago
Madison, WI, United States PCI Pharma Services Full timeA pharmaceutical services provider in Madison, Wisconsin, is seeking a QA Specialist I - Doc Control to manage CGMP documentation and maintain quality systems. Candidates should possess exceptional organizational skills, prior GMP experience, and a relevant degree. Join the team focusing on impactful therapies and patient care. Training and collaboration...
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CGMP QA Document Control Specialist I
2 weeks ago
Madison, WI, United States PCI Pharma Services Full timeA pharmaceutical services provider in Madison, Wisconsin, is seeking a QA Specialist I - Doc Control to manage CGMP documentation and maintain quality systems. Candidates should possess exceptional organizational skills, prior GMP experience, and a relevant degree. Join the team focusing on impactful therapies and patient care. Training and collaboration...
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CGMP QA Document Control Specialist I
2 weeks ago
Madison, WI, United States PCI Pharma Services Full timeA pharmaceutical services provider in Madison, Wisconsin, is seeking a QA Specialist I - Doc Control to manage CGMP documentation and maintain quality systems. Candidates should possess exceptional organizational skills, prior GMP experience, and a relevant degree. Join the team focusing on impactful therapies and patient care. Training and collaboration...
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CGMP QA Document Control Specialist I
2 weeks ago
Madison, WI, United States PCI Pharma Services Full timeA pharmaceutical services provider in Madison, Wisconsin, is seeking a QA Specialist I - Doc Control to manage CGMP documentation and maintain quality systems. Candidates should possess exceptional organizational skills, prior GMP experience, and a relevant degree. Join the team focusing on impactful therapies and patient care. Training and collaboration...
