Overview:

Support and coordinate efforts in the testing departments to foster quality and ensure that all pre-analytical, analytical and post-analytical processes are consistent with our company values and mission. Technical resource for assay quality and quality resource to maintain inspection readiness.

Department: Microbiology

Schedule: 8:00 am to 4:30 pm, Monday through Friday. (No Weekends) 

Responsibilities:

Promote continuous quality improvement by collaborating with management to implement standardization and process improvements.

Assist in the prompt and complete reporting of Reportable Quality Issues in compliance with the Standard Operating Procedure (SOP).  

Assist in the complete tracking of revised reports in compliance with the SOP.  

Train staff on QA/QC processes

Perform/assist with test/instrument/database validations and User Acceptance Testing

Act as a technical consult to staff as needed

Support 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 and Quest Diagnostics standards.  

Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations and CAP accreditation standards. May perform preliminary review of assigned department’s quality records and collaborate with management to investigate/resolve non-conformances.

Determine required enrollment and participation in proficiency testing for each test to include Corrective Action when necessary.  

Coordinate the Validity Check program and Blind Samples resubmission program, if applicable.  

Assist in maintaining a defined instrument-to-instrument, method-to-method, and laboratory-to-laboratory comparison process.  

Ensure compliance with document control policies for all procedures and related documents used in the assigned testing department’s quality program. 

Support the Corporate Quality Surveillance Program, Patient Results Distribution Program, Quality Control Program, corporate initiatives/database changes, and other monitoring programs specifically assigned by corporate Lab Operations and Quality Assurance. 

Perform internal audits as directed.

Perform special projects and other duties as assigned.  

Qualifications:

Required Work Experience:

Qualification as General Laboratory Supervisor as defined by CLIA '88

At least five years employment in a laboratory setting.

Experience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirements

Able to effect Quality Improvement through problem solving skills and knowledge of quality tools.

Foreign educated candidates must provide a detailed credential evaluation from IERF.  United States educated candidates must provide a detailed original transcript. (Required)

Preferred Work Experience:  

Experience in multiple laboratory areas preferred

Knowledge: 

Technical understating of clinical laboratory operations

Skills: 

Strong interpersonal communication skills in a manner that creates a positive environment

Able to promote and manage change 

Organizational, analytical, technical, and problem-solving skills  

Proficient in Microsoft Office (Word, Excel, and Outlook) 

Multi-tasking skills 

Demonstrated leadership skills through initiative, accountability, integrity, collaboration and success in motivating team members to reach objectives 

EDUCATION

Bachelor’s Degree(Required)

LICENSECERTIFICATIONS

ASCP Certification required 

EEO:

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets