Job Description
RRxCo is partnered with an exciting and fast-growing Biotech to hire a QA specialist to help bolster their resource.
The UK-based business established in 2010 focusing on antibody, protein and peptide drug conjugate medicines and technology. The bioconjugation team was formed in 2011 and moved into a state-of-the-art facility in 2018. The facility has been built for containment; with the safety of their people and the environment in mind, and bespoke laboratories have been designed specifically to accommodate highly potent bioconjugations.
Antibody Drug Conjugates combine the cell and tissue specificity of monoclonal antibodies with the cell-killing potential of highly potent small molecules and represent one of the fastest-growing sectors in the oncology field.
Summary
The Quality Assurance Specialist is responsible for maintaining the quality management systems, ensuring there is adequate QA support for production activities (including batch review), Project support, oversight of material management and approval of materials/ service providers, approval of validation documentation, audit support activities and other QA activities onsite.
Deliverables
1. Responsible for document review (batch documents, logbooks, Protocols, SOPs, forms etc.)
2. Use Quality systems to ensure compliance ...