Laboratory QA Analyst

• Effectively Coordinate with all of our satellite labs with regards to the following:

• Effectively coordinate with Laboratory Managers and Facility Managers for build-out of new labs.

• Ensure Local lab manager and lab director have proper & current Policies and Procedures
• Coordinate and conducts the LIS testing with all our satellite labs and Burbank Lab with I.T. department
• Assist in researching the Federal and State requirements of our out of state labs and in the submission of applications of permits and licenses of all our labs.

• Coordinate with different departments (data entry, liaison, specimen receiving, scanning, dispatch, stat trackers, laboratory) to create training and operating manual for all departments related to laboratory operations.
• Occurrence Reports - Prompt process of the daily internal occurrence reports which
  • Review the reports and supporting documents and add any missing documents or information important for the investigation.
  • Investigate to find the root cause of problems and errors. Check the accuracy of the internal occurrence report.         
  • Forward the internal occurrence report to the involved department supervisor(s) for further investigation and corrective action.
  • Review the corrective action documents submitted if complete and accurate.
  • Writes external occurrence reports if needed in a timely manner.
  • Tracks the 90 day re-assessment of employees if applicable.
  • Generates the monthly summary of occurrence reports.
  • Maintains accurately the occurrence report database.
  • CAP Proficiency Test – Responsible for tracking of Proficiency Test survey orders from arrival in the laboratory to resulting of the tests.
  • Follow the CAP PT Tracking Procedures
  • Making sure that all PT surveys ordered arrive on the set scheduled delivery date.
  • Making sure that all PT survey results are faxed before their due date.
  • Knowledge on how to log PT specimens (i.e. assigning of accession numbers)
  • Accurately entering in the orders in our LIS (LC.EPP)
  • Making sure that results are entered into our LIS.
  • Proper endorsing of the PT specimens and documents to the Lead CLS
  • Faxing of PT results to CAP
  • Updating the PT survey database with all the pertinent information in real time.
  • Ordering of CAP PT survey specimens
  • Communicating through email the arrival and due dates of PT surveys which includes other information needed.(i.e specimen numbers, CLS assigned, etc.)
  • Tracking of the PT scores received.
• includes but not limited to:
• CLS California Dept. of Public Health License, Nevada Lab Tech and Lab Assistant state license filing and tracking.
  • Ensures that all original or official duplicates of phleb and CLS licenses are on file and current.
• Lab License, CLIA, CAP, Medical Waste Permit applications / renewals submission and other licenses or permits required.
  • Completes all the paperwork needed for the lab license, CLIA and CAP certificates applications/renewals for all DL Labs.
• Lab Audits – Conducts lab internal audits/inspections to measure and adhere to state required regulations.
  • Ensures that corrective action is done if necessary.
  • Ensures that the lab audits are documented.
  • Works with Lab Leadership in preparing the laboratory to be inspection ready by the State, CLIA and CAP.
• Conducts research, compile data, prepares reports, recommendations or alternatives that address existing and potential problems.
• Must learn and be proficient in the laboratory LIS/CRT programs used by other depts.
• Must learn the procedure and operations of other departments.
• Writes and implements appropriate policies and procedures.
• Maintain and organize company documents not limited to policies and procedures, training, competency testing, legal documents and other documents as required.
• Maintain strict confidentiality in all aspects of the client, employee and laboratory records and documents.
• Assist the Laboratory Director, Lab Manager, Technical Supervisors, Lead CLS, VP of Laboratory Services, Quality Assurance Admin. Manager to be in compliance with the state and federal regulations.
• Filing and keeping of records up to date and in an organized manner.
• Train other departments of policies and procedures as needed.
• Should be able to investigate client complaints and make appropriate corrective actions. Ensures client issues/ or concerns are identified, investigated and resolved.
• Assists the QA admin. manager in maintaining quality standards of the laboratory and to facilitate the operations of the QA dept.
• Performs other duties as required.
• Review incoming phone calls, mail, emails, etc.
• Performs general office maintenance duties and other duties as required

 KNOWLEDGE AND SKILL REQUIREMENTS:

• High School graduate or equivalent.
• Minimum of 2 years experience working in a clinical laboratory.
• Advanced computer skills / knowledge of computer programs (MS Office, Adobe Acrobat professional)
• Ability to work independently and as part of a team and have a good sound analytical judgement and problem solving skills.
• Attentive to details and accuracy.
• Must have the ability to learn quickly, prioritize and execute multiple tasks in a high pressure environment.
• Proficient in written skills in the English language.
• Ability to work under pressure and meet expected deadlines.
• Ability to work in a fast paced environment.
• Ability to maintain effective working relationship with co-workers, clients and vendors.
• Must be able to conduct business in a professional and manner.

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