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Details
Posted: 13-Mar-23
Location: San Diego, California
Type: Full Time
Categories:
Academic / Faculty genetics / genomics
Academic / Research
Sector:
Life Science & Biopharmaceutical Companies
Preferred Education:
Some College
Internal Number: 2023P-0232
Job Summary:
The QA manager will play a critical role in the implementation and ongoing maintenance of the Bionano Laboratories Quality Management System (QMS). In this role the candidate will be responsible for coordinating and facilitating Quality Assurance standards based on CAP, CLIA and State of California regulatory requirements. The candidate will also be instrumental in monitoring internal quality metrics and standards to be reported to leadership on a regular basis.
Primary Duties and Responsibilities:
- Planning, implementation, and surveillance of the entire QMS and ensure compliance with CAP /CLIA and other regulatory agencies.
- Develop and monitor quality improvement initiatives, quality metrics and key performance indicators (KPI) in the laboratory.
- Perform quality review and approval of laboratory procedures, technical protocols/reports, and testing records.
- Analyze quality-related data, identify issues or trends, and make recommendations to management.
- Responsible for Document Control activities including creation and/or revision of documents, processing, routing, and review.
- Hosts monthly quality management review meetings and prepares minutes for approval by the laboratory director.
- Establish and monitor performance of company quality policies and procedures and objectives.
- Preparation, hosting, execution, and responses for client, regulatory and internal/external audits.
- Maintain, troubleshoot, monitor, and evaluate effectiveness of the Quality management System (QMS).
- In charge of all investigations, corrections and CAPAs for non-conforming events (NCE) and audit findings.
- Review and approval of all controlled documents, customer specifications, change control, test method and software validation.
- Review and release of reagent lot qualification, material receiving and quarantine, and disposition of nonconforming materials.
- Perform monthly reviews of maintenance records and coordinates inter-instrument validations.
- Work with cross functional teams in the design and development of new test methods and products.
- Provide guidance and train others on Quality System and Quality Assurance procedures.
- Perform additional tasks, as assigned.
Required Skills/Abilities:
- Previous experience working in a CLIA/CAP laboratory and clinical laboratory setting. Knowledge of GLP and GMP also valuable.
- Experience with Quality Management Solutions (e.g., MediaLab, Master Control, etc)
- Experience with complex life science systems and assays, including automated sample prep systems, preferred.
- Ability to work in a fast-paced environment and maintain quality standards determined by the clinical laboratory.
- Computer proficiency – MS Windows, MS Office, and database experience.
- Strong technical writing ability.
- Strong organizational skills, task oriented, excellent time management skills.
- Ability to multi-task; flexible and adaptable to changing priorities.
- Works well with limited supervision and as part of a team.
- Proven people, verbal, and communication skills. Demonstrate ability to negotiate assigned tasks with other departments.
Education and Experience Requirements:
- Bachelor’s degree in Science or other relevant field, or equivalent combination of education/ training/industry experience. MS, MBA or CLS certification a plus.
- Minimum of 3-5 years of experience in Quality Assurance and in a clinical laboratory setting with management or project management focus.
- Demonstrated success in managing quality systems.
- Previous experience with CLIA and CAP audits and knowledge of quality standards and regulatory regulations preferred.
- Life science industry experience preferred.
About Bionano
At Bionano, we are committed to unlocking understanding of genome biology to advance the promise of genomics in areas including cancer and human disease, agricultural bioengineering and genome discovery. Our optical genome mapping and analysis tools help researchers see true genome structure to fill in what’s missing from sequencing-based data.
At Bionano, we are invested in the success of our customers and users around the world, and are dedicated to supporting them with the tools, resources and support they need to achieve their goals and make a real impact on improving quality of life for all.
More Jobs from This Employer
https://careers.acmg.net/jobs/18307286/clia-qa-manager
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