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Katalyst CRO • Wilson, North Carolina, United States
Job Summary
They are interested in temperature mapping experience, specifically CTUs, stability chambers, or similar environments. Strong lab instrument experience. 5+ years of hands-on CSV in GxP environments. Experience with risk assessments, URS, IQ/OQ/PQ, deviations, reports
Job Summary
They are interested in temperature mapping experience, specifically CTUs, stability chambers, or similar environments. Strong lab instrument experience. 5+ years of hands-on CSV in GxP environments. Experience with risk assessments, URS, IQ/OQ/PQ, deviations, reports. Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q9, ALCOA+. Experience with lab instrument software.
Experience with CDS, LIMS and major vendor systems. Experience with Computer Software Assurance (CSA) principles. Experience with electronic testing tools (e.g. HPQC/ALM). GAMP or ASQ certifications. Degree in science or engineering.