Quality Assurance Manager (9849)
Laboratory | Marlborough, MA | Contract
InGenesis is currently seeking a Quality Assurance Manager for a direct hire position with our client located in Marlborough, MA. In this role, you will be responsible for leading, supporting, and coordinating efforts that foster quality and ensure that all pre-analytical, analytical, and post-analytical processes are consistent with the company’s values and mission.
Apply today and we’ll reach out to answer any questions you may have!
- Direct, advocate for and enable visibility of quality processes.
- Ensure accountability within all areas of the business unit.
- Direct internal inspection process of the business unit associated laboratories and specimen collection sites to ensure compliance with applicable federal, state, and local regulations, College of American Pathologists (CAP) accreditation requirements.
- Review and ensure that corrective action is implemented when non-conformances are found.
- Monitor published guidelines for revisions to regulations or accreditation standards and ensure laboratory compliance.
- Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations and CAP accreditation standards for all sites.
- Ensure all testing facilities/personnel have appropriate licensure and accreditation as deemed by federal, state, and local regulations.
- Collaborate with business unit management even if primary responsibility has not been assigned to QA.
- Identify all tests performed and ensure enrollment and participation in external proficiency testing for each test.
- For those tests not covered by external proficiency testing, ensure internal proficiency testing is performed.
- Ensure that all proficiency testing is reviewed and corrective action is complete for all non-conformances.
- Ensure that a Validity Check program is in place, as well as a Blind Samples resubmission program, if applicable.
- Ensure performance of required Corporate Quality Surveillance Program, Patient Results Distribution Program, Best Practice Team Initiative/Database Changes Verification Program and other monitoring programs specifically assigned by National Quality Assurance (NQA).
- Act as a contact for national Quality Control (QC) peer comparison programs and ensure enrollment and effective corrective action as appropriate.
- Ensure all duties are appropriately delegated as required by applicable federal, state and local regulations.
- Ensure compliance with all NQA standards as required.
- Perform other duties as assigned.
- Bachelor's degree in a chemical, physical, biological, or clinical laboratory science or medical technology.
- Preferred: Qualification as General Laboratory Supervisor as defined by CLIA '88.
- Preferred: Certification by American Society of Quality.
InGenesis is dedicated to placing people in positions that preserve life, improve lives and inspire others. This does not happen without passionate people, skilled colleagues who are motivated to create innovative solutions and deliver superior service to our clients. Founded in 1998, InGenesis manages thousands of employees, including pioneering healthcare, science, technology and pharma professionals. The workforce solutions company includes almost half of the Fortune 500 in its nearly 300 clients. It is recognized as one of the largest healthcare staffing firms, and InGenesis is the largest minority/women owned healthcare staffing firm in North America.
InGenesis is proud to be an affirmative action employer and is committed to providing equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. If you have a disability or special need that requires accommodation, please let us know by visiting our website at https://www.ingenesis.com/careers/site-accommodations.