Blueprint Genetics is on a mission to bring world-class genetics knowledge to mainstream healthcare. Our company is growing rapidly, and we are currently looking for a full-time Quality Assurance Coordinator II to join our operations in Seattle, WA. This is an exciting opportunity to provide world-class genetic diagnostics and clinical interpretation for rare inherited diseases in 14 medical specialties. Our promise is to provide clinicians and their patients with comprehensive and high-quality tools and resources for diagnosis of genetic conditions. In doing so, we provide possibilities for targeted treatment and individualized care for patients.
The QA Coordinator II position is responsible for the daily oversight of testing, issue resolution, maintenance of records and compliance with all procedures, regulations and policies. Responsibilities also include creating, coordinating, implementing and analyzing quality processes that ensure compliance with regulatory and company Quality Control/Quality Assurance/Quality Management standards.
- Is knowledgeable in assigned area within the QA department and manages additional projects in an independent environment.
- Maintain knowledge of laboratory regulatory requirements, to include accrediting agencies, federal, state, and local requirements as well as Blueprint Genetics and Quest Diagnostics policies.
- Organizes and participates in internal and external audits, as needed
- Responsible for reviewing department processes and Standard Operating Procedures (SOP) to assure that these accurately reflect current processes.
- Maintenance of records required for certifications/inspections and compliance with all procedures, regulations and policies.
- Ensures compliance with all applicable regulatory agencies through documentation, audits and corrective action.
- Preparing reports to be generated on a monthly and quarterly basis for use in the Quality Management meetings.
- Review and address issues around protected health information (PHI) investigations, reportable quality issues, and other non-conformances, ensuring that responses are accurate and complete as well as ensuring that immediate, short-term and long-term corrective actions are implemented.
- Proficiency Testing: Identify all tests performed and ensure enrollment and participation in external proficiency testing for each test. For those tests not covered by external proficiency testing, ensure internal proficiency testing is performed. Ensure that all proficiency testing is reviewed, and corrective action is complete for all non-conformances.
- Organizes and participates in management review and risk assessment activities
- Provides on-site consultation on quality and/or regulatory issues
- Participates/organizes vendor management
- Performs special projects as assigned
- Ability to travel up to 25% of the time
- Education Preferred: Bachelor’s degree from an accredited college or university required
- Work Experience: 2 year experience as a QA Coordinator or other non-entry level position in a clinical laboratory, preferably in Molecular Genetics laboratory
- Other: Demonstrated ability to communicate effectively both internally and externally with all levels of professionals via conference call, email and/or in face-to-face meetings.
- Demonstrated ability to manage multiple projects and to produce required deliverables by the established deadlines and with the appropriate level of detail and accuracy.
- Able to work independently and make decisions as needed to achieve these goals. Team oriented.
- Proven ability to work collaboratively, providing direction to and receiving feedback from peers and manager to resolve internal and external client issues.
What We Offer
- Generous health, dental, vision, life and disability insurance plans.
- Competitive paid time off and holiday policy.
- Traditional 401(k), FSA, HSA, EAP and commuter benefits.
- Chance to develop your skills further in a rapidly evolving business environment.
- Positive and international work environment with great people.
- We are a team of experienced, young professionals who share the passion to help patients and families with inherited disorders.
Blueprint Genetics is a Quest Diagnostics company. Quest Diagnostics is the world’s leading provider of diagnostic information services. http://www.questdiagnostics.com/