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QC Associate I

San Diego Metro Area, California

Post Date: 07/18/2017 Job ID: JN -072017-19559
Description:
  • Perform routine and non-routine analytical biochemical and molecular biology assays to support release, characterization and stability testing of raw materials, production intermediates and final goods.
  • Follow established protocols and SOP s to test raw material and components for QC acceptability.
  • Perform daily assignments following written procedures and SOP s.
  • Ability to troubleshoot instrument problems when necessary.
  • Conducting visual and measurement tests; rejecting and returning unacceptable materials.
  • Approves in-process production by confirming specifications; communication required adjustments to supervisor and generating NCR s and Change Orders when necessary.
  • Handles incoming inspection in a timely manner which includes but not limited to sample analysis, batch record review, historical trend reviews, and official documentation findings.
  • Careful documentation of lab procedures.
  • Ability to follow written procedures
  • Flexibility with schedule may be required.
  • Preperation, daily maintenance, and use of next-generation sequencing instruments and equipment.
Skills:
  • Self-starter, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential.
  • Requires a basic knowledge of and application of principles, theories and practices of the chemist profession.
  • Requires basic communication skills. Periodic contacts with other departments or individuals outside of the organization that requires giving or obtaining routine information related work being done.
  • Flexible: able to respond quickly to shifting priorities and meet deadlines
  • Basic molecular biology laboratory skills such as pipetting, PCR, gel electrophoresis, etc. required. Experience with DNA or RNA sample preparation, sequencing, qPCR, robotics and/or Illumina technology is a plus.
  • Experience and familiarity with instrumentation a plus.
  • Ability to understand and follow work instructions and perform molecular biology assays with minimal guidance after initial training.
  • Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint)
  • Knowledge of GMP documentation, required.
  • Demonstrated attention to details and accuracy, required.
Education:
  • BS/MS in Biology/Molecular Biology, biochemistry, chemistry or related discipline
  • 2 to 5 years of industry experience with Functional analysis QC of molecular-biology-based assays preferred, other QC, R&D or manufacturing experience will be considered.

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