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Waltham, Massachusetts Apex Systems
POSITION SUMMARY

This position will be responsible for the support of Clinical Operations and Laboratory Quality. Key responsibilities will be supporting the daily activities associated with the maintenance of the quality management system. This includes but is not limited to creation and maintenance of all licensure, certifications and permits, document control, personnel training and competency programs, internal and external audits, event management and continuous improvement activities.

ESSENTIAL FUNCTIONS

  • Work cross-functionally with Quality Manager and laboratory teams to ensure that controlled documents are updated and maintained.

  • Work with Quality Manager to support licensing and certification inspections and audits.

  • Assist in the operation and administration of the Clinical Quality Management System and assures compliance

    with applicable regulations (CLIA, CAP, State DOHs, NYS, CMS, FDA).

  • Perform internal assessments to ensure that the company follows applicable quality and regulatory requirements.

  • Provide support for external audits with regulatory entities and other corporate partners. This would include DOH inspections, College of American Pathologist, New York State and Pharma partners.

  • Develop, maintain, and analyze metrics for key quality indicators presented in periodic quality monitoring reports.

  • Collaborate with cross-functional teams to ensure that proper design and development activities are documented.

  • Collaborate with the business development / Pharma Service team to ensure that analytic services projects with partners meet applicable regulatory requirements.

  • Support Document Management for the organization.

  • Serve as the regulatory representative on committees and project teams as needed.

  • Follows company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in all company SOPs and other documented resources.

  • Performs other duties and tasks as assigned.

Education and Experience:

  • Requires a Bachelor's degree in a biological sciences or clinical laboratory sciences with 3-5 years of relevant experience in a regulated, high complexity testing laboratory environment

  • Experience working in Quality or a laboratory environment regulated by CLIA, CAP (College of American Pathologist) and New York State DOH is highly preferred.

  • Experience working with MediaLab Quality software a plus.

  • Experience supporting laboratory operations in a Google Cloud PlatformLP environment is a plus.

Knowledge, Skills, And Abilities:

  • Excellent oral and written communication skills.

  • Understanding of CMS regulations related to laboratory testing is required.

  • Attention to timelines/schedules is critical for regulatory compliance.

  • Attention to detail and the ability to multi-task.

  • Ability to collaborate with cross functional teams including scientific and administrative support staff.

  • Project management skills is a plus.

Information for External Organizations for which this role meets certifications:
  • CLIA Title Quality Specialist NYS Title Quality Specialist
  • Proficient in the use of computer applications and software, including Microsoft Office suite (Word, Excel, Outlook, etc.)
  • Ability to work autonomously to manage and prioritize multiple tasks at one time.
  • Strong analysis and problem-solving skills


EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or - provided by Dice