12 qa specialist jobs at 7 companies in Baraboo, WI
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QA SPECIALIST I - OPS
Madison, Wisconsin, United States
OnsiteFull Time
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
Scientific Protein Laboratories: Produces biological active pharmaceutical ingredients and pancreatic enzymes.
2+ YOEExecute on-site QA tasks including batch record review, raw material inspection/release, writing deviations/investigations/CAPAs, and supporting QA documentation; Bachelor's required and 2+ years cGMP experience.
Scientific Protein Laboratories: Manufactures heparin and pancreatic enzymes for the pharmaceutical industry.
2+ YOEBachelor's degree in scientific discipline, 2+ years cGMP experience, ability to review batch records, inspect raw materials, write deviations/CAPAs, and perform QA documentation.
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.
Arrowhead PharmaceuticalsNASDAQ: ARWR: Develops RNAi medicines to treat genetic and intractable diseases.
5+ YOEBachelor's degree in science or equivalent and 5+ years in a regulated environment. Requires GxP regulatory knowledge, cross-functional coordination, communication skills, and Microsoft Office and Smartsheet proficiency.
Lands' EndNASDAQ: LE: Retailer of apparel, footwear, and uniforms for all ages.
Research and resolve QA inventory discrepancies across warehouse sites, perform inventory adjustments and stock transfers, operate forklift/crane, use multiple warehouse and QA systems, and communicate with inventory groups.
Microsoft Outlook, RAMIDS, Microsoft Excel, Microsoft Word, WHSE, UHST, QA Audit, Business Objects, ILIN, ULOG, PORA, PROD, SKIQ, PPQU, Easytrieve
Arrowhead PharmaceuticalsNASDAQ: ARWR: Develops RNAi medicines to treat genetic and intractable diseases.
8+ YOEBachelor's degree in a scientific, technical, or related field or equivalent experience; 8+ years in pharmaceutical or biotechnology quality, including 4+ years in supplier quality; cGMP and regulatory expertise.
Quality Management System (QMS), document management platforms, standard office software
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.