- Must possess a Bachelor's degree in Medical Technology, Biology, or other related Biological Science
- At least 1-2 years of clinical lab experience required.
- Previous related quality experience highly desired
- Strong knowledge of FDA regulation, CAP and CLIA regulations, federal and state regulatory requirements, internal auditing, CAPA systems, SOP writing, and trending and analyzing data highly desired.
- Must be able to relate professionally with people and possess the following skills: organizational and time management, problem solving, written and verbal communication.
- Must possess visual acuity, speech clarity, and be able to sit and stand for long periods of time.
- Skills in MS Office specifically Word and Excel
Are you an experience Quality professional looking for a new challenge? Do you have an eye for details and a passion for quality? LabCorp is seeking a QA Analyst with high regulatory acumen for our Molecular Infectious Disease Department. In this role you will be responsible for supporting projects and activities as they relate to: quality management, quality assurance, quality training, and continual improvement of the department in relation to quality.Functional responsibilities include:
- Maintaining databases (eg, tracking activities of the internal audit program, tracking responses for external audits, and keeping information regarding personnel, equipment, and test menu up-to-date);
- Reviewing records for accuracy and completeness;
- Coordinating and tracking results of internal proficiency testing program;
- Tracking timely reporting of proficiency testing (PT) results, maintaining accurate records of PT handling, reporting, and follow-up;
- Collecting data and preparing local quality metrics reports as assigned;
- Reviewing any outliers associated with quality metrics reports and assisting with development of corrective action and follow-up processes;
- Working with department and quality managers to ensure new and revised procedures are appropriately
- implemented and documented;
- Performing quality audits and creating timely audit reports;
- Filing for necessary licensure, certification and/or accreditation as appropriate for the laboratory's test complexity;
- Working with appropriate individuals to identify trends, solve problems, troubleshoot and modify processes to prevent recurrence of problems;
- Keeping quality director and site quality managers informed of any significant issues affecting overall laboratory quality;
- Performing administrative support duties (eg, maintaining records, generating and sending communications and reports, entering data, answering phones, filing, etc); and
- Monitoring and responding to other quality issues as assigned or developed in the course of the other duties as described above.
Posting ID: 595966758Posted: 2020-12-31