PCI Pharma Services: Integrated pharmaceutical development, manufacturing, and global packaging services.
3+ YOEBachelor's degree in a relevant scientific field preferred; 3–5 years in pharmaceutical or biotech industry; 2+ years in QA Operations supporting late-stage clinical or commercial production; FDA regulations, investigations, CAPA, and risk management knowledge.
Microsoft Office, Microsoft Word, Microsoft Excel, FMEA, PHA, IQ/OQ/PQ
PCI Pharma Services: Integrated pharmaceutical development, manufacturing, and global packaging services.
1+ YOEObserve and monitor aseptic behavior in ISO classified cleanrooms, document and escalate deviations, support media fill and contamination investigations, and collaborate on continuous improvement.
Catalent: Global provider of drug development and manufacturing solutions.
Apply cGMP/ICH/FDA/EMA requirements, support deviations/change controls/CAPAs, review batch records and protocols, oversee cell bank inventory, and provide QA training; experience with TrackWise or ComplianceWire and Microsoft Office required.
AccurayNASDAQ: ARAY: Develops and manufactures radiation therapy systems for cancer treatment.
Master's in Medical Physics (or higher), experience supporting/troubleshooting Linac and treatment planning, treatment delivery and QA experience, customer support/training experience, ability to travel up to 50%, ABR preferred.
Specialist I - Quality Assurance Operations, Compliance
Madison, Wisconsin, United States
OnsiteFull Time
Catalent: Global provider of drug development and manufacturing solutions.
0+ YOEPerforms internal and customer audits, maintains licenses and controlled documents, authors SOPs, supports regulatory submissions, drafts validation plans, and uses metrics and statistical tools to support QA compliance.