Laboratory Quality Associate

Job ID: req3550
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 Vaccine, Immunity and Cancer Directorate mission is to provide scientific leadership and laboratory infrastructure to study immune responses to Human Papillomavirus (HPV), SARS-CoV-2 infection and vaccines as well as other cancer preventive strategies in the context of clinical and pre-clinical studies.

KEY ROLES/RESPONSIBILITIES
The Quality Associate performs all aspects of quality standards across the laboratory. Performs quality control on all laboratory testing and processes, monitors and performs equipment maintenance. Develops and monitors quality assurance standards for biospecimen repository and testing operation. Ensures sample management and testing are performed with utmost quality by working closely and onsite with laboratory personnel. Assists, guides, and monitors laboratory processes, adhering to Good Clinical Laboratory Practices (GCLP) guidelines. Performs evaluation of critical reagents, 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.

Specific duties will include:

• Follows all GCLP requirements for all assigned and unassigned duties.
• Works closely with laboratory personnel to perform 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.
• Assists laboratory with identification, documentation, investigation and follow up of quality events (deviations, corrective and preventive actions, etc.), working closely with Scientific Manager, Quality Manager, and laboratory staff.
• Evaluates critical reagents, performs bridge experiments to qualify critical reagents and release lots for use in laboratory testing.
• Reviews batch records, document review, quality control testing review, and test results for completeness, accuracy, and conformance to specifications; investigates deviations and plan corrective actions with laboratory management and assists with corrective actions, in conjunction with laboratory personnel.
• Conducts routine and non-routine analysis of samples, including Quality control samples, standards and reagents according to standard operating procedures (SOPs), if applicable.
• Review and approve assay qualification/validation test plans and summary reports.
• Perform required data analysis, review data, interpret data findings, investigates issues and reports abnormalities, troubleshoots analytical methods.
• Participates in the development of quality control samples and procedures.
• Assists monitoring equipment within the laboratory as well as performing equipment maintenance as needed.
• Reviews production, test, and equipment records.
• Provides quality related training to personnel as needed.
• Provides accessibility and quality support to the laboratory staff on an on-going basis.
• Assists with document control and archiving of laboratory records as needed.
• Provides hands-on support to Laboratory Manager and laboratory personnel to achieve quality and maintain GCLP across laboratory activities.
• Assists with ordering and maintaining inventory within the laboratory (e.g, PPE).
• Maintains safety and orderliness of the laboratory.
• Perform other related duties as assigned.

Basic Qualifications

• Possession of Bachelor's degree in Biology, Public Health or a related field 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 2 years of relevant laboratory experience, including Quality Control and/or Quality Assurance experience.
• Proficiency 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.

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.
• Quality 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.
• Excellent communication skills (written and oral).
• Ability to work effectively in a matrix and team-oriented environment.
• Ability to develop project master plan and schedules.
• Ability to identify and solve complex problems.
• Strong organizational and multitasking skills.
• A commitment to excellence in operations, the position requires leadership skills

Job Hazards

This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
Work may involve the use of potentially hazardous chemical or biological materials or may be located in areas where such materials are used
Work may involve working with dry ice for extended periods of time

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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