The Manager, Quality Assurance is responsible for supporting Clinical Lab based issues. This position tracks quality performance and makes decisions concerning the quality issues by working directly with departments in the Lab. This position works closely with the Clinical Laboratory Director to ensure patient safety, and ensure the highest quality products are produced.
- Manage a small team, which includes hiring, communicating company policies, coaching and counseling, administering performance appraisals, and enforcing company policies through appropriate disciplinary measures.
- Work with the Clinical Laboratory Director and with Quality Assurance department to improve and maintain CLIA/CAP Laboratory policies and other Quality System procedures.
- Maintain and improve Proficiency and Competency procedures.
- Conduct internal audits of laboratory processes, and safety procedures.
- Help manage the Clinical Laboratory Teams during CLIA/CAP and state inspections.
- Part of cross functional teams responsible for implementing new programs, tests, methods, instrumentation, and procedures using the appropriate design and development procedures.
- Work with Laboratory Personnel, Facilities, IT, and other cross functional teams to ensure compliance with Quality System Procedures, laboratory procedures, safety and HIPAA standards.
- Work with the Equipment QC and Reagent QC teams to ensure laboratory equipment and reagents meet performance specifications.
- Help to maintain Laboratory Information System (LIMS) by identifying information needs and problems; recommending improvements; establishing priorities; training employees; maintaining security and confidentiality.
- This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job.
- Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
- Must maintain current status on Natera training requirements.
- Employee must pass post offer criminal background check.
- Other duties as assigned.
- B.S. degree or equivalent; degree in Molecular Biology or equivalent Life Science field is preferred
- Minimum of 5 years of experience in a management role over QA personnel.
- At least 2 years of experience in CLIA regulated Labs and Quality Management Systems.
- Experience in the handling of biological samples in a BSL2 laboratory environment.
- Commitment to high level of customer satisfaction.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Effective verbal and written communication skills.
- Experience in writing laboratory SOPs and other QMS documentation.
- Experience in DNA amplification, sequencing, including NGS, is preferred.
- Proficient with Microsoft Office, Google-docs, and electronic conferencing applications
- Ability to organize and manage multiple priorities.
- Ability to work well in a team environment and cross departmentally.
- Proficient with Lab Vantage and Atlassian tools (JIRA, Confluence) is preferred.