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QA Specialist II

Frederick National Laboratory for Cancer Research

This is a Contract position in South San Francisco, CA posted January 1, 2023.

QA Specialist II Job ID: req2212 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.

Position Overview: This position description does not represent a specific job but represents a sourcing announcement for current and future open positions.

Our positions span a wide range of skills, so candidates who express an interest may be considered for upcoming positions at Frederick National Laboratory for Cancer Research.

PROGRAM DESCRIPTION The Vaccine, Immunity, and Cancer Directorate (VICD) of the Frederick National Laboratory is seeking a QA Specialist II to support biospecimen and repository operations.

The primary mission of the VICD is to provide scientific leadership and laboratory infrastructure to study immune responses to SARS-CoV-2, Human Papillomavirus (HPV) vaccines and other cancer preventive strategies in the context of clinical and pre-clinical studies.

This position is located in Frederick, Maryland.

KEY ROLES/RESPONSIBILITIES The Vaccine, Immunity and Cancer Directorate is recruiting for a QA Specialist II: Follows all GCLP requirements for all assigned and unassigned duties Performs evaluation of laboratory internal controls and deficiencies and assists with corrective action plans Develops appropriate risk management strategies and assists with implementation Writes SOPs and revisions, Quality Assurance plans, and guidance documents to assist laboratory staff maintain internal control and document control Assist with identification, documentation, investigation and follow up of quality events (deviations, corrective and preventive actions, etc.) Reviews batch records, document review, quality control testing review, and test results for completement, accuracy, and conformance to specifications; investigate deviations and plan corrective actions with laboratory management Review and approve assay qualification/validation test plans and summary reports Review production, test, and equipment records Provide quality related training to personnel Perform other related duties as assigned by supervisor or Program Director 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) in Biology, Public Health or a related field 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 two (2) years years of progressively responsible experience Laboratory experience is required Proficient with Windows and MS Office including Word, Excel, PPT Knowledge of the use of proper English/grammar/spelling/punctuation Ability to effectively maintain files and active records In addition to a commitment to excellence in operations, the position requires leadership skills and commitment to the mission Ability to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Candidates with these desired skills will be given preferential consideration: Experience in standard tissue culture and immunological/virological techniques including: aseptic techniques, cell line maintenance, production of plasmids and virus-like particles, western-blot, ELISA, Luminex assays, virus neutralizing assays and PCR Assurance experience in laboratories operating under GCLP/GMP/GLP/CLIA Familiarity with human research subject requirements and regulations Strong organizational and communications skills Ability to work in a fast-paced team and multi-task to achieve milestones within deadlines EXPECTED COMPETENCIES Excellent communication skills (written and oral) Ability to work effectively in a matrix and team‐oriented environment Strong organizational and multitasking skills JOB HAZARDS This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW) readytowork