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QA Audit Expert

  1. South Germany
  1. Contract
Competitive
24187/NK
  1. Compliance / Quality Assurance
Date Posted10 Jan 2020
We have an exciting opportunity to work remotely for a Biotech Start-Up organisation in Germany.

They are looking for someone with flexible availability over the course of the next 3 months to work for approx. 2 days per week from home office (give or take) to assist in preparing the organisation for Clinical Trials phase I and II.

They are looking for someone with a strong Quality / Audit background within the Biotech sector and in particular are looking for experience preparing for Clinical Trials and knowledge of Analytical Assays.

The role will involve:
  • Evaluate and audit the lab processes for clinical trials (phase I and II). You will be required to audit analytical assays including:
    • FACS analysis of PBMCs
    • Cell based assays
    • ELISA
    • Conduct a GAP Analysis on the equipment and methods
    • Support in setting up validation protocols – including some document writing
    • Report writing
    • Ensuring IHC and FDA guidelines are met to pass clinical trials.
 The following workflows and machines need to be evaluated:
  • Plasma prep from whole blood (Streck BCT tubes)
  • cfDNA prep from plasma (KingFisher Flex robot, Thermo Fisher)
  • ddPCR of cfDNA (QX200, BioRad) or NGS analysis (Illumina, NovaSeq 6000)
  • DNA and RNA sample prep (manual or on QIAsymphony robot, Qiagen)
  • Nucleic acid QC (Bioanalyzer, Fragment Analyzer, Qbit)
  • Library Prep and NGS analyses = exome sequencing and transcriptome analysis (enrichment with Agilent SureSelect or TWIST; automation on Bravo robot, Agilent; Hamilton Star robot)
  • Immunogenicity testing (intracellular cytokine staining of PBMCs and FACS analysis)
  • Immunohistochemistry of PBMCs and FACS analysis
  • Potentially: immunohistochemistry
Could this position be of interest to you? Please apply with a copy of your up to date CV today if so and we will be in touch with further details should your profile be suitable!



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