QA Audit Expert

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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