Quality Assurance Manager at Color Genomics
Burlingame, CA, US
Color believes that everyone deserves access to high-quality information they can use to improve and maintain their health. We are transforming how clinical-grade genetic testing is done by removing financial, educational, and geographic barriers. Our goal is to expand physician-supported access to genetic testing to help every person, everywhere live longer, healthier lives.
 
The Quality Assurance Manager will be responsible for overseeing the Quality Systems at Color, ensuring compliance with regulatory standards (CLIA, CAP, NYS, CE, HHS) in clinical operations while maintaining a lightweight, low friction QMS and implementing and managing a CGMBS training program. This role is highly cross functional and requires an individual who has strong interpersonal and excellent communication skills. The individual should also possess strong problem solving skills coupled with the ability to be flexible and resourceful without sacrificing quality. 
 
Responsibilities and Duties
  • Maintain laboratory licensure through periodic renewals, new applications, method submissions and managing the proficiency testing program.
  • Direct and perform internal and external audits related to regulatory, accreditation agencies and business partners. Demonstrate ability to maintain excellent positive relationships with auditors or regulatory agencies.
  • Administer and manage the document control system, incident reporting system and personnel documentation
  • Review all laboratory procedures and validation documentation for compliance following regulation and guidance
  • Identify procedural and systemic compliance risks and recommend continuous improvements that complements existing practices.
  • Oversee and manage quality system related meetings, collect and trend key performance indicators.
  • Review and follow up on non-conformances, deviations until closeout. Initiate CAPAs to address system deficiencies and drive implementation of corrective action plans. Guide and develop effective, low friction action plans utilizing QA tools with an emphasis on continuous improvement and a strong emphasis on quality. 
  • Interface and collaborate with multiple groups in the company to educate and ensure compliance in all aspects of the clinical process. Provide guidance in various decision making processes that align with regulatory requirements and work practices.
  • Implement and administer all aspects of a CGMBS training program including recruiting, creating and coordinating the program schedule, completing required paperwork.
 
Qualifications
  • Requires a bachelor’s degree preferably in biological science or engineering discipline. 
  • Medical Technologist preferred or equivalent.
  • 5+ years of experience in Quality in a regulated environment in the biotech field
  • NGS experience is strongly preferred
  • Professional certification is preferred (i.e. CQA, Six Sigma, CQM etc)
 
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.