The incumbent must have experience in quality systems managing hospital laboratories and manufacturing. Serve as the subject matter expert on QA/QC, cGMP, cGTP, cGLP, and CQI/CQM, ensuring that systems and procedures are compliant with applicable laws and regulations. Implement changes as needed in the area. Must be detail-oriented. Possess strong oral and written communication skills. Adept at problem-solving and decision-making. Responsible for re-certification activities (CAP, AABB, FACT, FDA, DOH, CLIA, and the JC). Knowledge of statistical analysis to improve quality. Document quality assurance activities (such as internal audits). Generate monthly QA reports and participate in quality improvement teams. Analyze audit outcomes and carry out appropriate corrective action procedures. Provide training and education to staff. These functions are performed in accordance with all applicable laws and regulations and Georgetown University Hospital’s philosophy, policies, procedures, and standards.
Maintains and recommends improvements to the Cell Therapy Manufacturing Facility Quality Plan. Ensures all sections are following the SOPs and meet the federal, state, and licensure guidelines.
Manages the change control process for policies, processes, and procedures, which may include the implementation of new/revised documents and the archiving of old documents. Maintains an updated index of all SOPs and archives obsolete SOPs, ensures that SOP changes are appropriately documented, and new and/or revised processes are validated.
Develops and reviews personnel training and re-training programs and implements a formal competency evaluation and proficiency testing programs. Coordinates all competency assessments, proficiency testing / alternative assessment testing, and document control for the CTMF.
Ensures validation plans exist and are executed according to internal SOPs, as well as external regulations. Ensures that procedures are in place for equipment qualification and revalidation after repairs, and for all new processes and equipment, and for all record-keeping systems. Ensures that all procedures and processes mentioned above are validated prior to implementation.
Investigates product complaints, deviations/incidents, and adverse reactions to identify, correct, and eliminate their contributing factors, within a designated period. Develops, recommends, and monitors corrective and preventive actions
Ensures that process control exists for product labels, which are reviewed prior to release.
Bachelor's degree in a health-related field. Advanced degree preferred: biomedical science, biotechnology, engineering, or a related technical field.
QA, Six Sigma, Project Management, or equivalent.
3-5 years of experience in cGLP and cGMP (i.e. stem cell or bone marrow processing) with 1-3 years of experience specifically in Quality Assurance. Previous experience with Phase I IND clinical trials. Working knowledge of AABB standards, FACT Common Standards for Cellular Therapy, 21 CFR 210 & 211, and ICH guidelines.
Excellent knowledge and skills in quality management in the field of cell therapy processing and cryopreservation. Able to set priorities and work under stress. Must be able to remain calm and tactful when resolving problems involving all levels of staff, patients, visitors, vendors, etc. Flexible and adaptable to changing conditions. Demonstrated ability to manage and prioritize multiple projects and meet deadlines. Excellent time management and organizational skills.
Experience interacting with regulatory bodies a plus
Demonstrated ability to work independently as well as part of an integrated team
About MedStar Georgetown University Hospital Cell Therapy Manufacturing Facility
MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital with 609 beds located in Northwest Washington, D.C. Founded in the Jesuit principle of cura personalis—caring for the whole person—MedStar Georgetown is committed to offering a variety of innovative diagnostic and treatment options within a trusting and compassionate environment.
MedStar Georgetown’s centers of excellence include neurosciences, transplant, cancer, and gastroenterology. Along with Magnet® nurses, internationally recognized physicians, advanced research, and cutting-edge technologies, MedStar Georgetown’s healthcare professionals have a reputation for medical excellence and leadership.
The Cell Therapy Manufacturing Facility (CTMF) at MedStar Georgetown University Hospital was founded by consolidating the previous Islet Cell Laboratory and Cellular Engineering Laboratory in May of 2016. The CTMF is registered with the FDA in accordance with 21 CFR part 1271. This facility works closely with MedStar Georgetown's clinical human islet transplant program, bone marrow collection program (BMCP), and bone marrow and stem cell transplant program (BMSCTP).
The CT...MF is comprised of five laboratory subsections that are, a class 10, 000 (ISO 7) cleanroom, quality control, cell processing, cryogenics, and a flow cytometry laboratory.
The CTMF quality control laboratory performs requisite testing for cell therapy products.
The CTMF cell processing laboratory supports the Bone Marrow Collection Program (BMCP), the National Marrow Donor Program under the BMCP, and the Bone Marrow and Stem Cell Transplant Programs at MGUH.
The CTMF Cryogenics Laboratory ensures long-term storage of cryopreserved HPC clinical products.
Flow Cytometry Lab in the CTMF provides the clinical programs and in-house manufacturing process with analytic testing services.
The CTMF is staffed with dedicated personnel who undergo continuous training, proficiency testing, and competency review. A Quality Assurance program is in place to monitor and verify compliance with regulations and to ensure consistent product quality.
The CTMF is registered with the FDA in accordance with 21 CFR part 1271 and operates under the current Good Manufacturing Practices (cGMP). The CTMF is accredited by the College of American Pathologists (CAP), the AABB (formerly the American Association of Blood Banks), and CLIA certified. CTM has been awarded FACT (Foundation for the Accreditation of Cellular Therapy) accreditation on January 10, 2018.
Our mission is to use our expertise for manufacturing and to support the development, processing, and packaging of safe, high quality human cell-based clinical products and services for early translational research, clinical trials, and therapeutic use of pancreatic islets and hematopoietic progenitor cells for MedStar Georgetown human islet transplantation and bone marrow and stem cell transplant programs.
Facilitate the CTMF's successful drive in the development of cell therapy products and services from the laboratory to the bedside.
Provide superior quality products and services for life science research and clinical applications, improving human health.
Create a self-improvement opportunity for all staff members by offering continuous training and retraining to fulfill growing cell manufacturing needs.