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This position is with the Institute of Translational Health Sciences (ITHS). The ITHS provides collaborative research networks for participating researchers through multi-institutional structures and solutions, one of which is the UW Gene and Cell Therapy Laboratory (GCTL).
ITHS, within the UW School of Medicine, has an outstanding opportunity for a Quality Assurance Manager.
Develop and maintain cGMP Quality Systems:
Change Control and Deviations: Evaluate change controls and deviations (Engineering, Equipment, Manufacturing, Material, and Process changes or deviations) for their regulatory impact as well as their suitability for the cGMP facility and processes. Manage the change control system to ensure change controls and deviations are addressed, investigated, and closed in a timely manner.
Corrective Action / Preventative Action (CAPA) management: Track and trend all deviations and change controls (as mentioned previously) to look for systemic issues that need to be addressed. Work with the Lab Manager and GCTL staff to come up with CAPAs that reduce errors, increase compliance, and maintain the regulatory needs of the cGMP facility. Manage the CAPA program to ensure they are implemented and closed in a timely manner.
Training: With the help of the Lab Manager, build training programs for each job description within the GCTL. Manage training programs to ensure all staff are being trained and are maintaining their training and qualifications.
Document Control: Manage the document control system by ensuring that document revisions and reviews meet department and regulatory standards. The document control system houses all of the applicable documents used in the GCTL, such as Standard Operating Procedures (SOPs), Manufacturing Batch Records (MBRs) and Material Specifications. Ensure that document revisions/reviews are done in a timely manner. Maintain the electronic document management system by uploading new documents, and changing the status of documents (i.e. converting active documents to retired, updating documents to the current revisions, etc.)
Reviewing production records and release of final products: Review all production records and documentation to ensure they are compliant and complete. Work with the Lab Manager to address any outstanding issues. Be the final reviewer and verifier that all documentation is complete. Review analytical data for acceptability. Determine if a final product can be released and used in human clinical trials based on, submitted test data and thorough review of production documentation.
Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends, including:
Environmental monitoring (EM) data: Enter EM data into the database. Generate reports on a quarterly basis to summarize the EM data and trend it against previous quarters and annual data. Work with the Lab Manager to address any data trending in the wrong direction (i.e. open a CAPA and manage it).
Process data: Evaluate and trend data generated during processes (non- environmental data) to ensure processes are consistent. Process drift may occur due to several variables (materials, equipment, operators, environmental, etc.). Each variable needs to be tracked and trended to ensure processes do not exceed any process specifications that may be applicable, or to advise adding new process specifications to ensure drift is in check.
Implement ongoing quality improvements based on analysis and internal audits: Take part in annual audits of the facility, and review all of the Quality aspects of the facility. Additionally, external audits may be required on a client-to-client basis. Findings from these audits will trigger corrective actions that will need to be managed, alongside the Lab Manager, so that they are addressed quickly.
Work with interdepartmental teams and/or outside clients on projects, meetings, investigations and improvement initiatives:
Each client with the GCTL will require some support from QA. Each project will have a different amount of Quality oversight, but it is expected that the QA manager will work with clients to ensure their Quality questions are answered and any investigations or corrective actions are communicated to the clients in a timely manner.
A minimum of 5 years' relevant experience
BS in a scientific related field
Experience within the pharmaceutical and/or biotech industry
Experience in Quality Assurance, preferably in the biologics field
Working knowledge and technical understanding of the manufacture and testing of biologics
Experience in reviewing cGMP/GLP related documents (SOPs, protocols, batch records, technical reports, etc.)
Working knowledge of cGMP principles with respect to FDA regulations
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Experience with cell and/or gene therapies
Knowledge of Phase I/II clinical trial regulations
| Employee must undergo blood borne pathogens and HIPAA Compliance training. |
Employee must be willing to work a flexible schedule in a highly regulated environment.
Appointment to this position is contingent upon obtaining satisfactory results from a criminal background check
The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Criminal Conviction History, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select Apply to this position. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment you will be prompted to do so the next time you access your My Jobs page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.