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Job Field: Legal Jobs
Location: Emeryville, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>TITLE: QC Validation SpecialistLOCATION: Emeryville, CaDURATION: 6 MonthsEvery day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an excitingcontractopportunity for a QC Validation Specialistatone of our top clients in Emeryville, CA.Duties:* This role will interact with Technology Development, Manufacturing, Research Development, Quality Control and Quality Assurance staff to ensure that method validation and transfer studies are appropriate for the methods intended use s and comply with applicable regulatory and company validation requirements* Develop and validate analytical test methods for immunodiagnostic products and intermediates in accordance with ICH/USP requirements and Quality Module guidelines* Write analytical method validation protocols, method validation summary reports, and method development reports* Review method development and validation data to ensure completeness and accuracy* Evaluate existing analytical method validation packages for accuracy and compliance with current ICH and Quality Module guidelinesRequirements:* Bachelors degree in Chemistry, Biology, or a related field* 10 years in a GMP environment Pharmaceutical or Diagnostics/Device industries with at least 5 years in analytical method validation* Highly experienced in executing analytical test method validation* Experienced in protein chemistry and immunochemistry methods such as SDS-PAGE, ELISA, reversed phase and size exclusion chromatography, absorbance assays, and Western Blots* Excellent written and communication skills, scientific report writingIn addition to working with the worlda

KEY REQUIREMENTS:

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