Quality Control Coordinator II | Lenexa, KS
Monday to Friday
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.
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/AEducation Preferred:
Associates degree or equivalent required with college level courses preferredWork Experience:
2+ years' experience and demonstrated performancePhysical 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 professionals via conference call, email and face-to-face.
• Demonstrated ability to prioritize and manage multiple tasks.
• Demonstrated ability to produce required deliverables with appropriate level of detail and accurateness and meet established deadlines.
• Able to work independently and make sound decisions as needed.
Proven ability to work collaboratively across multiple functionsOther
• Data management skills in Microsoft Excel applications.
• Experience with Microsoft Word.
• Familiar with lab environment and requirements.2022-16987