Quality Control II Coord - Novi, MI
Schedule: 8AM-5PM
Look for more than answers. Patients and Physicians rely on our diagnostic testing, information and services to help them make better healthcare decisions. These are often serious decisions with far reaching consequences, and require sensitivity, tact and a clear dedication to service. It's about providing clarity and hope.
You will work for the world leader in the industry, with a career where you can
expand your skills and knowledge. You'll have a role where you can act with
professionalism, you can inspire colleagues, and you can care about the work we do and the people we serve.
At Quest, we are on a continuous journey of discovery and development. It's this attitude that has made us an industry leader and the #1 Diagnostic Lab in the US. For those joining us, we offer exciting and fast moving career opportunities where you can affect change at a rate unheard of in many organizations of our size and scope. While we invest in and develop technology to drive our innovations, our ongoing success relies on our people.
Basic Purpose:
The Quality Control Coordinator II ensures Health & Wellness testing events meet regulatory compliance and is inspection ready at all times. Responsible for the maintenance of instrument records, continuous improvement, field issue resolution and record keeping required for inspections. Duties are performed in compliance with all procedures, regulations and policies in adherence Federal, State, and County Health Department regulations. The QC coordinator is responsible for QC functions in all 50 states, which includes the West, Midwest, Southwest, South, East, and North regions. Event volumes requiring QC coordinator functions range 1000 - 3500+ a month.
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Duties and Responsibilities
*Perform pre-analytical reagent control, including reagent prequalification testing. Provides direction to internal departments on releasing new lots for distribution to utilize at CLIA waived events. Performs troubleshooting for reagent lots falling outside manufacturer standards and communicate findings to QC supervisor and Medical Director.
*Perform pre-analytical reagent preparation, including aliquoting samples, labeling, and assembly. Responsible for ensuring acceptable QC products are provided for distribution to utilize at CLIA waived events, certifying accurate results are reported to patient populations.
*Perform analytical role in providing instrument technical support and QC troubleshooting techniques to all Health & Wellness testing personnel, ensuring proper execution of event QC before, during, and after events when required.
*Provide pre-call support to testing personnel, instructing on proper QC technique and providing feedback to inaccuracies, ensuring compliance with CLIA requirements before testing is performed
*Perform post-analytical QC related activities such as collecting QC from Wellness Engine system and/or oversight of manual tabulation of QC data by Business Partner, while also maintaining electronic files and quality control records.
*Review of QC documentation for accuracy and troubleshooting detected issues. Escalates QC failures for investigation.
*Prepare QC documentation for state laboratory inspections, confirming event records are accurate and related corrective action documentation are available, to ensure requirements are met to pass inspection and maintain state licensure.
*Perform audits on outgoing supply shipments for applicable mobile laboratory testing sites to ensure compliance in state inspections. Perform audit on inventory control processes and maintains manual and computer records associated.
*Performs inventory control for quality control reagents and supply ordering to support 1000 - 3500+ events monthly, ensuring sufficient amounts needed for onsite events.
*Troubleshoot returned POCT instruments by testing optical and QC performance. Release suitable devices back into service or return defective devices to the manufacturer.
*Monitoring laboratory instruments performance, calibrations, and expiration due dates. Perform calibration checks and record results. Release suitable devices back into service or return defective devices to the manufacturer.
*Promptly assisting the Health & Wellness provider network in fulfilling biomedical waste return container requests and invoicing.
*Demonstrates excellence in customer service skills to develop and retain customer relationships.
*Team oriented; works collaboratively, providing direction to and receiving feedback from peers and Supervisor to resolve internal and external issues.
*Notify appropriate departments of reportable problems, assist in corrective actions, as needed, and monitor corrections to assure compliance.
*Must be knowledgeable in departmental processes and Standard Operating Procedures (SOP).
*Must be knowledgeable in state by state regulatory laboratory requirements.
*Projects a positive, professional demeanor at all times.
*Perform other quality control duties as required by the QC Supervisor.
Supervision Exercised: N/A
Qualifications:
Education Preferred:
•Associates degree or equivalent required with college level courses preferred
Work Experience:
•2+ years' experience and demonstrated performance
Physical and Mental Requirements
•Ability to move / transport 10 lbs
•Must be able to remain in a stationery position
•Perform job duties with frequent interruptions or distractions
•Performs a variety of duties, often changing from one task to another
•Maintain composure under pressure
* Demonstrated ability to communicate effectively both internally and externally with all levels of... For full info follow application link.
Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Orientation / Gender Identity.
