Job Description:
Responsible for the lifecycle of regulated and clinical samples of bio therapeutics in various matrices to be tested in ligand binding assays on various instrument platforms.
Responsible for the routine and non-routine maintenance of lab equipment (e.g. plate washers, plate readers) used in support of regulated and clinical studies.
Assist with quality control of operational procedures and software applications in accordance with departmental SOPs and bio analytical methods.
Sample lifecycle management and lab equipment maintenance to be governed per departmental SOP. Attention to detail to ensure accurate execution and documentation of these processes in a regulatory compliant manner. Knowledge of GLP/GCP and working in a regulated environment is highly desirable.
Implement various processes needed to manage a sample鈥檚 lifecycle which includes accession, check-in and disposal within a laboratory management system (LIMS). Become proficient in LIMS to conduct these activities in a dynamic environment. Collaborate with external groups to resolve sample discrepancies. Assist in the transmission and formatting of clinical files for the importation/exportation of clinical data from LIMS.
Execute routine maintenance of lab instrumentation as required per departmental SOPs.
Education experience:
BSc with at least 1+ year relevant experience, with a focus on sample management / ligand binding assay validation/sample testing; preferably in a GLP/GCP laboratory.
路Industry experience with a focus in bio therapeutics; familiarity with LIMS and instrumentation used in execution of ligand binding assays.
路Skills in GLP/GCP compliant laboratory including following SOP and provision of quality regulatory documents is highly desirable.
Integrated Resources INC
https://careers.smartrecruiters.com/IntegratedResourcesINC