Quality Associate

Burlingame, California /
Clinical – Lab Operations /
Full-Time
Named by Rock Health as the Best Digital Health Company to Work For, Color is a leading healthcare technology company. Color is building and delivering technology-enabled healthcare to millions of people. Through partnerships with public and private partners including governments, employers and health systems, Color’s infrastructure and software enables large populations to receive essential healthcare services directly where they live or work. This includes testing and telehealth services for preventive health and infectious disease management.

Since March 2020, Color has mobilized to address the pandemic by leveraging its platform to scale COVID-19 testing programs around the country. Color’s platform is used by more than 100 major employers, universities and public health institutions, such as the City of San Francisco, the State of California and PerkinElmer, community-based efforts in Oakland, and others, to deliver critical health programs. For more information about Color and its response to COVID-19, visit www.color.com.

By investing in the technology that ensures easy and affordable access to healthcare, Color is creating the infrastructure that will serve us for decades to come. Apply to join Color and do some of the most important work of your career. If you are not sure that you're 100% qualified, but are up for the challenge - we want you to apply!

We are looking for someone to join our Quality Assurance team to help support the Quality Management Systems (QMS) at Color, ensuring compliance with regulatory standards such as 21 CFR Part 493 (CLIA), CAP, and New York State Department of Health (NYSDOH). The Quality Associate will oversee document control and training programs for the organization. This position will be the SME on the eDMS and provide training and support for internal customers. This person will be responsible for overseeing the training files and program for the laboratory personnel and eventually implement a QMS training plan for the organization. This role will create and deliver QA training for new hires and to personnel that require Introduction to Quality, GDP, Incidents, internal/external audit preparation. One of the goals for this role will be to gather feedback and implement improvements for both document control and training. This is a full-time employment position. 

How You’ll Contribute:

    • Maintain, track and ensure completion of personnel documentation for the clinical laboratory. 
    • This includes Competency Assessments, new hire onboarding documentation, training, Continuing education (if necessary), licensure and qualifications.
    • Maintain signature logs. 
    • Track licensure status for the laboratory, submit and file renewals, new licensures and changes. 
    • Present status of personnel documentation and licensure at quality review meetings.
    • Administer Document control system. Update or write new SOPs as required and complete chain of approval for document review. 
    • Responsible for the scheduling and carrying out the Quality related training program for new hires and the team.
    • Maintain, update and deliver training content on Overview of Quality, GDP, Incident Reporting as well as additional new modules. 
    • Participate and support internal audits and external audits from regulatory bodies or customers/partners.
    • Participate and support other quality team initiatives and ongoing activities such as reagent qualification, instrumentation validation and batch record reviews. 

Our Ideal Candidate Will Have:

    • A Bachelor’s degree or equivalent in science, engineering, or related field.
    • Min 1 year of experience in CLIA/CAP laboratories, medical devices, or life sciences industries.
    • Working experience with an organization that has an established QMS is preferred. 
    • Document Control experience 
    • 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:

    • Familiarity with MediaLab, JIRA, lab processes 
    • Prior experience supporting a fast paced environment 
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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.

COVID-19 Vaccination Requirement: Color requires anyone working onsite or visiting Color’s offices to confirm they are fully vaccinated against COVID-19 unless a medical or religious accommodation is timely requested and approved.  Please reach out if you have questions or concerns about this policy and how it may apply to your candidacy for a role with Color.