Quality Assurance Manager

Research Triangle Area, NC /
Lab Operations /
Full time
About Us
Glympse Bio is pioneering the development of synthetic biomarkers – biochemical sensors developed using breakthroughs in science, engineering, medicine and artificial intelligence – that are engineered to be tunable to a range of diseases and offer earlier measures of response to disease and treatment. Our breakthrough technology measures protein activity from a blood draw to revolutionize disease diagnosis and monitoring. We are building a novel biomarker technology platform from the ground up, laying the foundation for innovative diagnostics which combines nanotechnology with AI to improve the lives of potentially millions of patients worldwide.
 
We are a vibrant and dedicated team working at the forefront of scientific discovery and clinical development. We are agile, resilient, and creative problem solvers. We are committed to bringing the best products to patients and at Glympse you will have the opportunity to work alongside a high functioning, interdisciplinary and collaborative team to develop an entirely new diagnostic modality.

Position Summary
Glympse Bio, in conjunction with Lighthouse Lab Services, is hiring a Quality Assurance Manager for our new clinical laboratory.  We are looking for a motivated and experienced QA clinical laboratory scientist that has a background in quality assurance and molecular diagnostics.  This leader will oversee the development, implementation, maintenance, and performance of the company’s quality system and provide support for internal and external audits.  This position will give the ideal candidate an opportunity to build and shape a lab from the day it opens. The role and the lab will be well supported by the existing organization, with access to all the resources you need to be successful. 

Responsibilities

    • Develop, implement, and manage QA systems, conduct periodic reviews of QMS, and implement corrective actions. 
    • Conduct internal audits for clinical sample analyses to ensure compliance with CLIA/CAP and GxP, as applicable. 
    • Facilitate external audits, evaluate audit responses, and follow up on responses and audit closure. 
    • Write QA SOPS and provide regulatory input for other CLIA SOPs; draft, review, and update Lab SOPs in conjunction with the technical supervisor.
    • Prepare and analyze the quality control section of the monthly report including non-conformance reports; log relevant documentation and investigation.
    • Assure regular equipment maintenance is performed. 
    • Assist technologists with reagent qualification design. 
    • Track and determine receipt, quarantine, release and rejection of reagents; obtain quality documents.
    • Design, analyze and prepare reports for process updates and validations. 
    • Prepare and organize lab proficiency testing program, credentialing and licensing renewals.
    • Prepare lab for biannual CAP/CLIA inspections. 
    • Review equipment status forms, maintenance reports, calibration reports, cleaning check sheets, function check sheets, and OOS forms. File calibration certificates and equipment manuals. 
    • Responsible for facility safety management and reporting including, but not limited to, OSHA record keeping, monthly reporting, accident investigations and hazard analysis. 
    • Other duties, as assigned. 

Qualifications

    • Bachelor's degree in Molecular Biology or related science and 10+ years’ experience in a startup molecular diagnostics laboratory.
    • 4+ years of QA/QC supervisory experience and proven track record of successfully leading and developing a team
    • Ability to analyze data and create and review processes 
    • Proven success collaborating with interdisciplinary teams in a fast-paced environment 
    • Ability to independently learn, understand, and utilize current and developing CLIA standards 
    • Highly adaptable and comfortable in an environment with dynamic priority demands 
    • Self-motivated and effective at managing multiple projects in parallel 
    • Strong oral, written, and presentation communications skills 
    • Detail-oriented, thorough, and rigorous  
    • Thrives in a collaborative, dynamic and fast-paced work environment 
The Ideal Candidate
·       Brings courage, character, humility, and energy to work every day
·       Is motivated to improve the lives of the people they serve
·       Is excited about what might be possible, sees problems as challenges to be overcome, and is driven by curiosity and creativity
·       Is optimistic and committed to Glympse’s mission

EEO Disclosure
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law.