1 year contract with option to extend!
Purpose of Role:
Currently QC is looking for an enthusiastic and dedicated analyst to -
Support activities in the areas of qualification of critical reagents (biomaterials) used in Bio-assays, such as ELISA coats, ELISA conjugates, reference toxins etc,
To support analytical method validation and method transfers between labs.
Key Accountabilities and Duties:
Validation – ability to work on several projects simultaneously and be able to prioritise. Reporting and communication of results to stakeholders. Liaise with several departments - technical support groups, QA, Regulatory to drive project completion and deliver on milestones.
Validation of biomaterials used in in-process and final product testing. This will include technical writing of protocols, testing and execution of protocols and writing final reports.
Analytical method validation and test transfer between labs/sites.
Equipment validation - assist lab leads in executing validation of new equipment.
Expertise in Immunology techniques such as ELISA’s, haemagglutination tests, antigen mass assay is essential.
Good understanding and ability to perform efficient lab investigations arising from deviations or invalid/atypical results.
Comply with Standard Operational Procedures (SOP’s), GMP, ESH procedures and MSD corporate policies and process improvements.
Maintain all documentation and training records as per GMP requirements.
Incorporate MSD Production System and Inclusion within the department activities and work with colleagues to innovate and implement processes.
To comply with company’s health and safety practices and procedures.
Ensure positive, timely and effective communication with team members and internal customers.
Good understanding and working knowledge of GMP Quality Systems
Subject Matter Expert in ELISA’s and other immunology techniques
Minimum 5 years of experience with excellent understanding of testing within a laboratory environment
Validation and method development