Quality Specialist IV in Frederick, MD

Description

Quality Specialist IV

Job ID: req1540
Employee Type: exempt full-time
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.

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.  

 Position Overview:

PROGRAM DESCRIPTION

The Clinical Services Program's primary mission is to perform sequential studies using samples obtained from 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 Vaccine, Immunity and Cancer Program investigates immune responses to vaccines in preclinical and clinical studies, with a focus on HPV.

KEY ROLES/RESPONSIBILITIES

The Vaccine, Immunity and Cancer Program is looking for a Quality Assurance Specialist to lead QA activities. The QA specialist will:

• Lead and perform evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards
• Work with Lab director and manager to plan, qualify, verify, and validate tests/assays and equipment
• Identify risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them
• Develop appropriate risk management strategies
• Recommend alternative courses of action and possible solutions for improvement of workflow, and paperwork management
• Assist with the creation, implementation, and follow up of Corrective and Preventive Actions
• Write SOPs and quality assurance management plans
• Participate in the review and revision of standard operating procedures to adhere to regulatory regulations
• Prepare standard operating procedures for quality control
• Ensure compliance with SOPs, FDA, and GCLP/CLIA regulations
• 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
• Review documents for completeness, track and monitor assigned projects
• Assist with audits. May perform audits
• Implement training programs. Train laboratory personnel on quality assurance requirements, processes, and procedures

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• In addition to education, a minimum of eight (8) years of relevant experience in Quality Assurance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Leadership in the field of Quality Assurance
• Experience in reference materials QC, immune assay (ELISA, multiplex assays) development and validation
• 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

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)

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