Quality Assurance Specialist II, CLIA

The Cancer Research Technology Program (CRTP) develops and implements emerging technology, cancer biology expertise and research capabilities to accomplish NCI research objectives. The CRTP is an outward-facing, multi-disciplinary hub purposed to enable the external cancer research community. A major focus of the CRTP is the NCI RAS Initiative with the goal to discover new therapeutic interventions against RAS-driven cancers. In addition, the CRTP hosts the Nanotechnology Characterization Laboratory (NCL) which performs and standardizes preclinical efficacy and toxicity testing of nanoparticles intended for cancer therapeutics and diagnostics, the Antibody Characterization Lab (ACL) which characterizes monoclonal antibodies or other renewable affinity binding reagents for use in cancer related research and the Clinical Molecular Diagnostics Lab that provides Sanger sequencing and gene expression microarray-based mutation detection CLIA certified services for clinical investigations. CRTP scientists also work collaboratively with intramural NCI investigators to provide research technologies and expertise.

KEY ROLES/RESPONSIBILITIES

The QA Specialist II will be responsible for monitoring activities within the Clinical Molecular Diagnostics Laboratory.

Primary duties will involve:

• Monitoring laboratory assay results, assuring complete and accurate documentation of all laboratory activities related to patient testing, participating in meetings to review results, preparation of reports and documents as required to meet contractual or regulatory requirements
• Directly supporting the document review of clinical assays for CRTP and CMDL initiatives in support of clinical studies and initiatives
• The QA Specialist II works independently under the general guidance of the CLIA laboratory manager
• Performing daily temperature monitoring, and SOP drafting utilizing sound judgment
• Writing assay validation plans, and assessing validated clinical assays in a CLIA accredited laboratory
• Contributing to review of maintenance of all equipment
• Record keeping, scanning, filing, archiving, and often require problem solving
• Performing quality control evaluations; Assignments include assisting with presentations and/or scientific publications
• Planning proficiency testing and observing competency assessments, and evaluation of assay control performance over time
• The QA Specialist II may be exposed to potentially hazardous chemicals, biological or radiological materials or may be located in areas where such materials are used; The use of personal protective equipment and strict adherence to safety protocols will be required

This position is located in Frederick, MD.

BASIC QUALIFICATIONS

• Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
• In addition to the educational requirements, a minimum of two (2) years of experience in a regulated laboratory setting
• Must be able to obtain and maintain a security clearance
• Ability to independently evaluate the suitability and quality control of research and production assays or tests, analyze and report data. Possess knowledge of basic subject matter of specialty (i.e. molecular biology, cancer research, clinical assays, good laboratory practice)

PREFERRED QUALIFICATIONS

• Excellent writing and grammar skills, knowledge of document versioning, organizational skills, CLIA and/or FDA expertise, experience with standard operating procedures (SOPs), time management skills, communication skills, adept in Microsoft Word, Excel, PowerPoint, Access, Outlook, FileMaker Pro and Laboratory Information Management Systems (LIMS) databases, Adobe, secure e-mail.
• CLIA laboratory experience and working with human samples. Demonstrated abilities to trouble shoot and take corrective action. Ability to dedicate focused attention to assay performance and notice assay trends. Familiar with clinical research and clinical assays and other protocol-driven clinical research a plus.
• Understanding of genetics and genomics assays and parameters highly desirable. Familiarity with RNA and/or DNA extraction and assessment techniques a plus. Able to work independently with minimal supervision. Detail-oriented and multi-tasking.
• SOP writing, ability to understand current scientific data and compare controls to samples, pass/fail results, observe historical trends, keen eye for document review to detect errors, familiarity with CLIA competency assessments, proficiency testing, quality assessments, deviation documentation, corrective and preventive actions, equipment maintenance and calibration data review, criteria for specimen rejection, equipment and test validation requirements, reagent verification, temperature monitoring.
• Stringent record keeping, team player, unidirectional lab workflow skills, molecular lab experience