Quality Assurance Specialist, HPV Serology Lab (NCI)
The Clinical Services Program's primary mission is to perform sequential studies of immune function in patients with cancer, AIDS, chronic granulomatous disease or other diseases associated with immunologic dysfunction, as well as to monitor viral load in patients with HIV.
The HPV Serology Laboratory (HSL) at the Frederick National Laboratory develops qualified reagents, standards and serological assays for evaluation of immune responses to HPV vaccines. In addition, the HSL works with various partners on studies of immunogenicity of HPV vaccines in vaccine trials.
Quality Assurance Specialist
- Assists and supports the laboratory with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for production
- Works with the Lab Scientific Manager and Director to develop and implement standard operating procedures and quality control/assurance procedures
- Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards
- Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them
- Facilitates internal training on quality control and assurance requirements, processes, and procedures
- Works in the laboratory and conducts experiments
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Bachelor's Degree in relevant field; Degree must be from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/scientific discipline (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
- In addition to the education requirements, a minimum of five (5) years of relevant experience
- Experience in immune assay (ELISA, multiplex assays) development and validation
- Must be able to obtain and maintain a security clearance
Candidates with these desired skills will be given preferential consideration:
- Experience in biological standards development
- Experience in high throughput testing and robotics
- Experience with LIMS used in immune monitoring laboratories
- Experience in quality control and quality assurance related to immunology, virology and/or molecular biology procedures for reagent production and assay development and performance
- Strong understanding of regulatory and GCLP requirements
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