Quality Assurance Engineer

Posted 1 year ago
Job Description:

  • Perform 21 CFR Part 11, DIA, EQA assessments on QIA Symphony, Illumina MiniSeq, Genedata, Video Graphic Recorder & KingFisher Magnetic Particle Processor
  • Investigate the deviation in CTP protocol execution to analyze the root cause of the test failures and record the CAPA as per the SOP
  • Use Isotrain, Kaye thermocouples, Empower, LIMS and Production equipment, Kaye Validator, Data loggers & CTUs to conduct temperature mapping studies.

Work Location: Work at various unanticipated work locations throughout the U.S. Relocation may be req’d.

Minimum Requirements:

Education: Bachelor – Pharmaceutical Science (will accept foreign education equivalent)
Experience: Two (2) years. Experience must include 2 years with FDA Regulations 21 CFR Part 210, 211, 820 and 11, Annex 11, GAMP guidelines, HPLC, PCR, Quality Metrics (Q30, Q20) and Genomic Material.

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