Clinical Lab Quality Assurance Manager
NKGen is seeking a highly experienced and motivated Quality Assurance Manager. The QA Manager is responsible to evaluate, design, and implement lab quality assurance program. Ensure that the laboratory is compliance to all regulatory requirements as well as to ensure continues accreditation and certification of clinical lab and blood bank donor center. The Clinical Laboratory Quality Assurance Manager will be responsible for monitoring the lab quality management program, implement new plan for improvement and to meet with updated requirements. The QA manager will maintain and control of all documents including SOP, policies and forms pertaining to the lab operations.
- Manage the development and continue review to update of SOPs
- Maintain all SOP and QC/QA documents under lab document control system
- Design, develop, implement, and monitor clinical lab and blood bank donor center to continually improve quality assurance program
- Utilize root cause analysis to evaluate systems failure
- Initiate and conduct CAPA process on non-conformance incident
- Use of metrics, benchmarks, and indicators for quality assessment
- Responsible for Proficiency Testing scheduling and events
- Perform internal audits (CAP interim, competency assessments, quality indicators, periodic audit of QM Plan)
- Review and conduct all activities in preparation of periodic inspection from accreditation agencies
- Ensure all laboratory activities are performed in accordance with State and Federal requirements
- Oversee all instrument and technical systems’ periodic maintenance scheduling and conformance
- Maintain all documentation required for licensure purposes
- Lead QA meetings and discuss findings and recommendations for resolving non-compliance
- Take steps proactively to improve quality systems
- Identify problems, outline solutions, and drive execution
*The company reserves the right to add or change duties at any time.
Job Qualifications & Skills
- Knowledge of word-processing, spreadsheet, and database applications.
- Knowledge of document control in lab environment
- Knowledge of CAP/CLIA regulations and guidelines
- Experience in AABB standards and implementation
- Strong interpersonal skills
- Excellent problem-solving skill
- Effective organization, communication, and team-oriented skills
- Ability to initiate assigned tasks, work independently, prioritize workload, and manage multiple projects effectively
- Maintain positive work environment with colleagues and external partners.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Detailed oriented with outstanding interpersonal and communication (written and verbal) skills.
- Education: Bachelor's Degree Required
- Experience: 7 years’ experience in quality assurance within CAP/CLIA/AABB environment required
- California Clinical Laboratory Scientist License and certified MT/MLS ASCP preferred
Benefits & Perks
- Competitive compensation
- Medical, Dental and Vision Insurance
- Business casual work attire
- Fully stocked kitchen and much more!