Research Assistant III GMP
The Research Assistant IIIreports to the cGMP Manager and independently performs specialized techniquesin an FDA-regulated core lab to develop, manufacture, test cellular basedproducts for quality and ship investigational cellular products for therapeuticuse in human phase I/II clinical trials. The cGMP Research Assistant III ensuresall activities in the lab complies with Federal, State and local regulationsand policies. WHAT IS EXPECTED (ESSENTIALFUNCTIONS) · Performs experiments to define the cellular product(s),manufactures and QC tests and releases qualification batches and batches for human phase I/IIclinical trials. · Creates study specific SOPs, lab forms and clinical forms. · Coordinates with other BSWRI core facilities for study samplecollection, processing, storage and analysis · Works closely with PIs and GMP Manager to plan and executeanalytical methodologies to support sponsor/investigator project. · Trains users and assures that equipment is validated, maintainedand operated according to SOPs · Establishes written procedures and develops plans for monitoringclinical investigations · Develops appropriate monitoring activities based on the complexityof the protocol, number of subjects, rate of enrollment, SOP and staff experience. · Conducts sponsor scheduled site visits. Maintains records offindings, conclusions and action taken to correct deficiencies for each visit. · Verifies that investigator and/or designee and all involvedresearch staff follow the approved protocol and all applicable federal and local guidelines and GCPguidelines · Prioritizes and adjusts workflow and schedules to meet demands ofmultiple projects, and assure that necessary supplies are available · Assists with maintaining accreditation requirements · Assists in selection of new instrumentation, validatingtechnologies and optimizing, revising, revalidating existing analytical methods and procedures · Involves working long hours in a clean room with restrictivegowning. Location/Facility Baylor Scott & White Research Institute For more information on the facility, please click our Locations link. Specialty/Department/Practice GMP Lab Shift/Schedule Day Shift with some overtime and occasional weekend work Benefits Our competitive benefits package includes: Immediate eligibility for health and welfare benefits 401(k) savings plan with dollar-for-dollar match up to 5% Tuition Reimbursement PTO accrual beginning Day 1 Note: Benefits may vary based upon position type and/or level. QUALIFICATIONS - EDUCATION - Bachelor's - EXPERIENCE - A minimum of 5 years experience required Must have cell culture andBSL2 experience. Must have experience with gooddocumentation practices, working in a clean room and knowledge of regulatoryrequirements (FDA, CLIA, GMP, GLP, etc.). Clean room gowningexperience preferred. Ability to troubleshootinstrumentation and perform maintenance tasks. Use of statistical,analytical or presentation software related to work. Flexible schedule requiredas early/late and/or weekend work is involved.