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Associate Scientist

San Diego Metro Area, California

Post Date: 06/28/2017 Job ID: JN -062017-19397
This position provides technical collaboration for product development programs or projects involving department or cross-functional teams focused on validation of inspection methods used during assembly of consumable products.

  • Perform late stage analytical development, qualification, validation and transfer of inspections methods for consumable products.
  • Develop and execute validation protocols for inspection methods used at all levels of consumable manufacturing.
  • Analyze test results, draft validation/engineering reports and make technical recommendations.
  • Participate in project management meetings as analytical methods validation representative determining validation requirements, as needed.
  • Learn and understand the applicable technology and engage in technical discussions.
  • Provide expert technical input with respect to method validation requirements and related Regulatory requirements.
  • Ensure test method validation program meets requirements of FDA (21 CFR Part 11) and ISO.
  • At least 3-5 years of experience in analytical method development, qualification, validation and transfer.
  • Minimum 2-3 years of technical writing in many of the following areas: validation protocols, validation reports, SOPs, engineering/ development reports, validation master plans.
  • Must be an effective communicator, able to effectively lead teams and interface well with the organization.
  • Strong user level experience with many of following techniques: biochemical (enzyme) assays, binding capacity assays, UV/fluorescence spectroscopy, HPLC and qPCR.
  • Expert knowledge and working application of method validation principles for regulated industries including: FDA cGMP; ICH/USP guidelines ANSI/ISO/ASQC; FMEA, Risk Analysis and Design Controls.
  • Experience with statistics, Statistical Process Control and DOE techniques is desired
B.S./M.S. in Biochemistry, Molecular Biology, Chemistry or similar field

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