QA Audit Expert
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
- 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.
- 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
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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