Quality Associate at Color
Burlingame, CA, US
Recently named by Rock Health as the 'Best Digital Health Company to Work For,' Color is a leading healthcare technology company. Color makes population-scale healthcare programs accessible, convenient, and cost-effective for everyone. Color works with health systems, employers, and national health initiatives around the world including the million-person All of Us Research Program by the National Institutes of Health. 
 
Since March, Color has mobilized to repurpose core parts of its infrastructure for a massive COVID-19 response and helped fundamentally change the access model for COVID-19 testing across massive public health programs (including the City of San Francisco and community-based efforts in Oakland), major U.S. employers, and universities. For more information about Color and its response to COVID-19, visit www.color.com.
 
We are looking for someone to join our Quality Assurance team to help oversee the Quality Management System (QMS) at Color, ensure compliance with regulatory standards such as 21 CFR Part 493 (CLIA), CAP, and New York State Department of Health (NYSDOH).  The Quality Associate will be taking a variety of responsibilities, including document control, training, and internal and external audits.  This is a full-time employment position.

How You’ll Contribute:

    • Administer, maintain, and oversee the electronic document management system and the document control process.  Responsibilities include providing users document control training and guidance, monitoring documents for periodic review, and making improvements to the document control process as appropriate.
    • Oversee and maintain the training program, which includes structuring documents for ease of reading and training per role, ensuring personnel files are up-to-date and complete, and providing Quality training for new employees.
    • Participate in internal and external audits (CLIA, CAP, NYSDOH, supplier, customer/partner).
    • Support nonconformance review for supervisor approval and closure.
    • Prepare, review, and revise, as required, standard operating procedures and other supporting work instructions per CLIA, CAP, and NYSDOH regulations. 
    • Provide QA review on documentation that requires QA feedback.
    • Engage in continuous improvement activities by identifying opportunities and recommending improvements in the QMS processes.  
    • Maintain knowledge of relevant quality and regulatory standards to meet changing requirements.  
    • Participate in special projects and perform other duties as assigned.

Our Ideal Candidate Will Have:

    • A Bachelor’s degree or equivalent in science, engineering, or related field.
    • At least 1-2 years experience in CLIA/CAP laboratories, medical devices, or life sciences industries.  1 year experience working in a Quality role preferred.
    • Knowledge of CLIA, CAP, NYSDOH regulations. Excellent interpersonal, verbal, and written communication skills.
    • Independent worker, self-starter with strong organizational and planning skills.
    • Prior experience in a start-up environment that is fast paced and willing to accept temporary responsibilities outside of the initial job description.

Nice to Have:

    • Professional certification (i.e. American Society of Quality certification in Quality Engineering, Quality Auditing, etc.).
    • Next generation sequencing (NGS) experience. 
    • Familiarity with electronic document management system, SQL, and Tableau.
Color is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. Color prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Color conforms to the spirit as well as to the letter of all applicable laws and regulations.