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QA Audit Expert

  1. South Germany
  1. Contract
  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!

The candidate must have the rights to work in the location stated in the job advert.

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