Quality Assurance Officer-Intermediate

Exton, PA

Posted: 09/08/2022 Job Number: 21719241 Pay Rate ($): 43.0

Job Description

Quality Assurance Officer-Intermediate

Pay Rate: $43 / hour

" Quality Assurance Officer
Minimum Qualifications
A bachelor' s degree or higher in a microbiology, medical laboratory technology, clinical laboratory science, biology, biochemistry, molecular biology, or a related laboratory science.
At least one year of experience developing quality policies and/or conducting audits for compliance in a laboratory that performed microbiology and/or molecular biology testing.
Experience in a clinical laboratory that conducted testing on human specimens for the purpose of obtaining results used for medical diagnoses. This experience may include adhering to the laboratory' s established quality policies, though an active role in developing and/or enforcing quality policies is preferred.
Knowledge of the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations clinical laboratory accreditation requirements such as those set by the College of American Pathologists (CAP).
Strong ability to read, understand, review and revise laboratory policies and procedures, including test standard operating procedures, with a keen attention to detail.
Proficiency working with Microsoft Office software programs.
Excellent time management, documentation and organizational skills; ability to work well under pressure and adapts quickly to change.

Role Description:
Serves as a resource to aid the Bureau of Laboratories (BOL) in meeting regulatory requirements related to quality and generally improving the quality, efficiency, and effectiveness of BOL operations. Focuses primarily on work conducted in the Division of Clinical Microbiology but also addresses issues that affect multiple areas of the BOL.
Develops and/or maintains knowledge of statutes, regulations, professional standards, and accreditation requirements applicable to a public health laboratory that performs clinical testing. These include, but are not limited to, the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA), the CLIA regulations and interpretive guidelines, the Pennsylvania Clinical Laboratory Act and associated regulations, and standards from organizations such as the Clinical Laboratory Standards Institute.
Provides guidance on regulatory compliance, best practices, and quality improvement to supervisor and other members of upper management including the Bureau Director who serves as the CLIA laboratory director for the whole Bureau of Laboratories (BOL).
Develops and/or updates written policies, processes, and procedures to improve the BOL' s quality practices and create a comprehensive quality manual that specifies requirements for topics including personnel qualifications, duties, training, and competency assessment; standard operating procedures; document control; validation of new laboratory tests; calibration; quality control; test orders; sample/specimen quality; maintenance; proficiency testing; audits; and corrective actions
Utilizes document management software to maintain quality system documents and related records. Develops written processes and procedures to enable other staff to properly use the software
Prepares training materials and educates staff on the contents of the quality manual.
Develops and/or maintains knowledge of processes and procedures for verifying/validating new laboratory test procedures based on CLIA regulations and recommendations found in CLSI standards, reference books, and scientific journal articles.
Works with management and bench-level laboratory staff to investigate problems, determine root causes, and develop corrective action plans. Ensures that corrective action plans address root causes and that follow-up to assess effectiveness is completed and documented.
Works with the BOL' s existing Quality Officer to coordinate quality-related activities across laboratory divisions and implement single, BOL-wide policies, processes, and procedures whenever feasible.
Works with the Safety Officer when quality and safety issues overlap.
Works with the information technology (IT) staff when modifying, adding, and validating IT resources, such as the Laboratory Information management System (LIMS), laboratory web portal, or computerized temperature monitoring system to improve quality.
Works with the Administrative Officer when back-office functions such as procurement, supplies storage, shipping and receiving, and facility issues may impact the quality of laboratory testing.
Conducts internal audits to ensure adherence to the requirements or recommendations in statutes, regulations, professional standards, accreditation requirements, and the BOL' s quality system. Audits will cover the pre-analytic (e.G., sample/specimen quality, handling, accessioning, storage and transport to laboratories), analytic (e.G., laboratory test procedures, validations, calibrations, quality control, record keeping), and post-analytic (e.G., results recording and reporting) phases of clinical laboratory operations.
Participates in any audits conducted by external organizations.
Documents audit findings and presents them to management along with recommendations for corrective actions, when applicable.
Analyzes data from individual audits and across multiple audits to identify trends and systemic problems.
Assists directors in enrolling in proficiency testing programs to monitor the accuracy of testing. Reviews proficiency testing performance and notes need for corrective action when applicable. Circulates proficiency testing results for review by directors, supervisors, and testing personnel.
Provides input into programmatic plans and financial decisions, including grant proposals, when quality-related considerations must be considered.
Identifies opportunities for quality improvement projects and participates in projects with BOL teams and Department of Office of Operational Excellence.

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