Assist the cell processing team with daily preparation activities as it relates to Cellular Therapy product processing and infusion procedures under rigorous current Good Manufacturing Practices and Good Tissue Practices, for use in both the pediatric and adult clinical, traditional and new therapeutic processes. Position will be primarily in support of clinical processing in preparing calendar, cleanliness of processing facility in accordance to SOPs and ensuring availability of critical clinical supplies by daily check of inventory and expiration dates.Job Duties
- Prepare cell processing and / or administration documentation to ensure all applicable documents are available, correct and in place prior to product processing and/or transplantation.
- Participate in equipment and reagent qualification and maintenance procedures to ensure appropriate use and compliance with manufacturer and regulatory standards.
- Ensure materials, reagents and equipment are within the established calibration and expiration dates/times prior to use.
- Ensure the Cell Processing Facility is adequately stocked with materials, reagents and supplies to prepare all currently manufactured stem cell products and gene therapy products (when applicable).
- Assist in preparation of facility for audits, inspections and accreditation visits.
- Retrieve and collate sterility records to match with appropriate patient charts.
- Assist clinical data managers with location of patient records and documents as appropriate.
- Able to openly communicate with transplant physicians, nursing and all other support staff on abnormal findings in documentation as appropriate.
- Perform electronic data entry into CAGT databases, collation of documents for reports and audits, generation of reports and summaries, assistance with materials management ordering.
- Receive, ship and store (placing in LN2 freezers) cell products.
- Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
- One year of relevant experience.
Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.