Lead GCLP Quality Assurance

Lead GCLP Quality Assurance Job ID: req4127 Employee Type: exempt full-time Division: Vaccine, Immunity and Cancer Facility: Frederick: ATRF Location: 8560 Progress Dr, Frederick, MD 21701 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases. Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way. PROGRAM DESCRIPTION The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases. The Vaccine, Immunity, and Cancer Directorate (VICD) at the Frederick National Laboratory has a primary mission to provide scientific leadership and laboratory infrastructure to study immune responses to Human Papillomavirus (HPV) vaccines, other cancer preventive strategies and SARS-CoV-2 in the context of clinical and pre-clinical studies. Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest. KEY ROLES/RESPONSIBILITIES The Vaccine, Immunity and Cancer Directorate is seeking an energetic, collaborative and seasoned Quality Assurance professional with experiences preferably in Serology laboratory setting with strong knowledge in GCLP to lead and support laboratory quality activities. This is a fully onsite position with no telework option. This is a temporary assignment with a potential for permanent appointment. The QA professional will: Lead continuous performance evaluation of internal controls, communications, risk assessments and maintenance of documentation, including SOPs, as related to compliance with internal and external safety, quality, and regulatory standards for GCLP Evaluation and monitoring of conformance to established quality assurance processes and standards for testing and laboratory practices Identify risk and evaluates deficiencies and deviations in a routine basis while working with internal departments/business units to appropriately remedy them Develop appropriate risk management strategies Assist staff with the creation, implementation, and follow up of Corrective and Preventive Actions Implement and develop appropriate Corrective and Preventive Actions Program in collaboration with VICD management/leadership. Recommend alternative courses of action and possible solutions for improvement of workflow, and paperwork management Work with laboratory director and manager to plan, qualify, verify, and validate tests/assays and equipment Working closely with the laboratory to write SOPs and Quality Assurance plans appropriate for each group Participate in the review and revision of standard operating procedures to adhere to regulatory regulations Working closely with appropriate staff, prepare standard operating procedures for quality control activities Review documents for content, accuracy and compliance Develop and monitor quality assurance standards Prepare guidance documents Review records, test results and data for completeness, accuracy, and compliance with specifications and requirements Facilitate internal training and quality assurance requirements, processes, and procedures, and maintain training records for staff Maintain document control system and ensure version control for all standard operating procedures Lead and perform internal audits, identify deficiencies, recommend improvements and make risk assessments Implement training programs for laboratory personnel on quality assurance requirements, processes, and procedures Ensure compliance with SOPs, GCLP/CLIA regulations, and FDA as applicable BASIC QUALIFICATIONS To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency In addition to the education requirement, a minimum of eight (8) years of experience working in GCLP or GLP environment Trained in GCLP or GLP Excellent communication, organization, and writing skills Ability to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: 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/CLIA requirements Experience working with standards and reference materials, immune assay (ELISA, multiplex assays) development and validation JOB HAZARDS This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations Commitment to Diversity All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws. $74,800 - $128,625 The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data. readytowork