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Performs and directs assays according to, and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs.
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The QAU will support the comparable GMP production activities related to GLP toxicology lot production and technical transfer activities as it relates to clinical batch release testing conducted at GTP to support the clinical CMO. The QAU will also provide Quality Assurance support to the research-based portion of the GTP, in terms of SOP management, training, document management and archiving, and audit support.
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Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., FDA, EMEA, GCP, GLP, GMP, QSR, etc.) Experience in developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC and IT infrastructure phases.
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Inspect testing facilities to ensure framework is in place for studies to be conducted in compliance with GLP requirements. Advise staff on GLP policies. Inspect testing facilities to ensure framework is in place for studies to be conducted in compliance with GLP requirements.
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Supervise Molecular Laboratory staff performing testing of patient and blood donor samples submitted for DNA testing to predict red cell, platelet and white cell antigens. Perform testing utilizing platforms including single nucleotide polymorphism (SNP) panels involving end-point detection of SSP-PCR, bead-based extension reactions, MALDI-TOF mass spectrometry and Sanger sequence analysis of genomic and cDNA. Interpret results and patient report generation, preventative maintenance of laboratory equipment and qualification of reagents.
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Products or Services Sold - Analytical Services for Cell and Gene Therapy, GLP Bioanalysis, Manufacturing of Biological Products. Our client is a growing CRO who is looking to grow one sector of their business which is analytical testing in the Cell and Gene therapy space.
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