Writing protocols, reports, and compiling data and attachments into validation packages to meet regulatory/accreditation requirements according to CLIA/GCP/ISO.
Ensure the integrity of data systems through trouble shooting, configuration and change management, as part of life cycle management.
Support the development and implementation of LIMS, which includes configuration and programming, system validation (GAMP), SOPs, development, end-user training and site administration
Operational ownership of automated liquid handling systems and related software tools, including developing and programming pipetting methods, developing interfaces (LIMS), system validations, systems documentation, and ensuring successful implementation in the lab.
Reformat and transfer clinical study sponsors data according to data transfer specifications (DTS) including associated documentation to ensure regulatory compliance
Oversee the acquisition, operation, calibration and maintenance of laboratory equipment in accordance with the site quality system as an equipment manager.
