LSTC - Manager of Quality and Compliance

Location
Massachusetts, United States
Salary
Salary Not specified
Posted
Aug 25, 2020
Employment Level
Administrative
Employment Type
Full Time


LSTC - Manager of Quality and Compliance

About Northeastern:
Founded in 1898, Northeastern is a global research university and the recognized leader in experience-driven lifelong learning. Our world-renowned experiential approach empowers our students, faculty, alumni, and partners to create impact far beyond the confines of discipline, degree, and campus.

Our locations—in Boston; Charlotte, North Carolina; London; Portland, Maine; San Francisco; Seattle; Silicon Valley; Toronto; Vancouver; and the Massachusetts communities of Burlington and Nahant—are nodes in our growing global university system. Through this network, we expand opportunities for flexible, student-centered learning and collaborative, solutions-focused research.

Northeastern's comprehensive array of undergraduate and graduate programs— in a variety of on-campus and online formats—lead to degrees through the doctorate in nine colleges and schools. Among these, we offer more than 195 multi-discipline majors and degrees designed to prepare students for purposeful lives and careers.

About the Opportunity:
For the Life Sciences Testing Center (LSTC) on Northeastern University Innovation Campus at Burlington, we seek a Manager of Quality and Compliance to oversee quality-related activities for our new lab. The successful candidate will implement plans to continuously strengthen our existing quality culture and assure lab standards and all related regulatory expectations are met as per our quality management system.

This role will also be accountable for monitoring and assuring corrective actions and preventative actions (CAPAs) as appropriate, maintain our document management system, facilitate and track compliance and appropriate ongoing lab training, own Quality Assurance / Quality Control (QA/QC) functions, and oversee change control processes.

This role reports to the Technical Supervisor in the Life Science Testing Center at Northeastern's Innovation Campus at Burlington, MA.

This is an 18-month term positions with the possibility of renewal depending on funding and business need.

Responsibilities:
Responsibilities:
  • Ownership of the Quality Function within the lab, including but not limited to: Documentation Management, Compliance and Role-Related Training, QA/QC, CAPAs and Change Control Processes
  • Accountable as the lab's expert resource for continuous improvement and ongoing development / maintenance of quality and compliance in accordance with CLIA Regulations (state and federal) and other regulations as required
  • Serves as a primary contact for, and then coordinates and participates in, regulatory-related inspections; leads management of all documentation and key inspection activities, including readiness and appropriate protocols
  • Oversees appropriate quality metrics
  • Collaborates with Lab General Supervisors and Clinical Technicians to listen to and generate ideas for continuous improvement and risk identification / mitigations

    Qualifications:
  • Bachelor's degree in related field required, advanced degree preferred
  • 5+ years of relevant experience in a quality role within a clinical laboratory environment; at least 2 years in a CLIA Accredited clinical laboratory
  • Knowledge of and practical application with CLIA Regulations, cGLP and other quality-controlled standards
  • Ability to determine key quality metrics in a “start-up” lab environment
  • Experience in various aspects of quality: documentation control, tracking of training, change control processes, CAPAs and quality events
  • Experience in high complexity Molecular Environment
  • Ability to influence and collaborate within a high-volume lab environment
  • Ability to integrate the necessary adherence to compliance and quality standards with various lab priorities and a high performing, diverse lab team


    Preferred Qualifications:


    Salary Grade:
    12

    Additional Information:
    Northeastern University is an equal opportunity employer, seeking to recruit and support a broadly diverse community of faculty and staff. Northeastern values and celebrates diversity in all its forms and strives to foster an inclusive culture built on respect that affirms inter-group relations and builds cohesion.

    All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, religion, color, national origin, age, sex, sexual orientation, disability status, or any other characteristic protected by applicable law.

    To learn more about Northeastern University's commitment and support of diversity and inclusion, please see www.northeastern.edu/diversity.



    To apply, visit https://careers.pageuppeople.com/879/cw/en-us/job/503723

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