Gclp Quality Assurance Specialist I/Ii

GCLP Quality Assurance SpecialistI/II

Job ID: req3863
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.

The Vaccine, Immunity and Cancer Directorate investigates immune responses to vaccines in preclinical and clinical studies, with a focus on HPV and more recently on SARS-CoV-2.

As part of a large effort to combat the current SARS-CoV-2 pandemic, the National Cancer Institute (NCI) is collaborating with the National Institute of Allergy and Infectious Disease (NIAID), the Centers for Diseases Control and Prevention (CDC), the Food and Drug Administration (FDA), the Frederick National Laboratory (FNL) and other stakeholders to develop assays with the highest reproducibility, sensitivity, and specificity for evaluation of immune responses against this new virus. 

To address gaps and unmet needs in serology assay development and standardization and to gain a solid fundamental knowledge of the immune response to SARS-CoV-2 and underlying mechanisms of protection against infection, NCI has established the Serological Sciences Network (SeroNet), which includes the Frederick National Laboratory (FNL) Serology Lab, leveraging the vast expertise and excellence in HPV serology at the FNL. 

The Quality Assurance Specialist performs all aspects of quality standards across the laboratory. Performs Quality Assurance on all laboratory testing and processes, maintains document control. Develops and monitors Quality Assurance standards for all laboratory operations.

Assists, guides, and monitors laboratory processes, adhering to Good Clinical Laboratory Practices (GCLP) guidelines. Performs evaluation of internal controls, communications, risk assessments and documentations, deviations related to compliance with internal and external safety, quality standards. Works with laboratory to plan, qualify, verify, and validate tests/assays and equipment. Reviews documents for completeness, track and monitor assigned projects. This position is located at the Advanced Technology Research Facility (ATRF) in Frederick, Md. Frequent travel to laboratory units in Fort Detrick is expected.

This is an onsite position with no telework option.

In addition, the Quality Assurance Specialist will:

• 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 Quality Assurance Manager, laboratory director, and manager to plan, qualify, verify, and validate tests/assays and equipment
• Identify risks and evaluate 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 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; track and monitor assigned projects
• Assist with audits; may perform mock audits
• Implement training programs; train laboratory personnel on Quality Assurance requirements, processes, and procedures

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) in Biology, Molecular Biology, Immunology, or related field. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• Quality Assurance Specialist I - No experience necessary with related Bachelors Degree
• Quality Assurance Specialist II - In addition to the education requirement, a minimum of 2 years of related experience 
• Ability to obtain and maintain a security clearance

Candidates with these desired skills will be given preferential consideration:

• Experience working in GCLP or GLP environment
• 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
• Excellent communication and organization skills

• Work may involve the use of potentially hazardous chemical or biological materials or may be located in areas where such materials are used.   
• 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.
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