*Sign on Bonus eligible* Quality Manager-San Diego, CA
Location: San Diego
Posted on: September 12, 2021
Laboratories, a wholly-owned subsidiary of Laboratory
Corporation of America Holdings (LabCorp), is a CAP accredited and
CLIA-certified molecular diagnostics lab located in San Diego, CA.
Sequenom is dedicated to the development and commercialization of
laboratory-developed tests (LDTs) which improve healthcare by
providing revolutionary genomic analysis solutions for the clinical
research and molecular diagnostic markets.
Location: 3595 John Hopkins Court San Diego, CA 92121
Manager is responsible for the Quality programs, systems, processes
and procedures and that the performance and quality of services
conform to established regulatory and accreditation requirements
within the assigned laboratory or geographic region. Leads the
internal and external audit program and resolution of audit and
inspection findings; manages the internal and external proficiency
testing program, manages the nonconforming event program and
facilities continuous improvement. Oversees compliance with CLIA,
CAP, ISO 15189 and other regulatory and accreditation
position reports into the Associate Quality Director and/or Quality
- Promote a
culture of quality
- Partner with
laboratory leadership to develop quality goals and
- Ensure all
laboratories within the assigned area(s) maintain current federal,
state and local licensure and accreditations, as
guidance for laboratories in implementing policies with respect to
regulatory and accreditation requirements.
laboratories to identify quality issues, nonconformities and
opportunities for improvement.
responses to accreditation and regulatory citations, nonconforming
events and complaints.
- Perform root
cause investigations and monitor outcomes, corrective action and
process improvement activities.
summary data for management reports regarding quality indicators,
internal and external audit outcomes, and complaints.
- Host Quality
Management Review Meetings and prepare minutes
in Quality Department improvement projects
- Assist in
policy and procedure creation for Quality Systems
- Provide and
ensure training for LabCorp quality policies and
- Maintain and
coordinate communications between laboratories in the assigned
area(s), provide assistance where indicated on quality related
- BA/BS degree
in Biology, Chemistry, Medical Technology, or other related science
or in the field of Quality Management, 5+ years in Quality
Assurance and/or Quality Management preferably in a clinical
diagnostic laboratory and 2 years of supervisory
knowledge of CLIA/NYS and CAP regulations. ISO 15189 experience a
- Must possess
excellent verbal/written communication and presentation
Keywords: Labcorp, San Diego , *Sign on Bonus eligible* Quality Manager-San Diego, CA, Other , San Diego, California
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