QA Specialist II, CGR, NCI Connect Study

Job ID: req4591 Employee Type: exempt full-time Division: Clinical Research Directorate Facility: Frederick: Ft Detrick Location: PO Box B, Frederick, MD 21702 USA The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses urgent biomedical science challenges, including cancer, AIDS, drug development, and rapid response to emerging infectious diseases. Program Description The BioProcessing and Trial Logistics (BPTL) team plays a vital role in advancing translational research through expert biospecimen lifecycle management. By integrating best processes in laboratory operations, BPTL ensures that biospecimens are collected, processed, stored, and documented with the highest standards of quality and integrity. We are seeking a Quality Assurance Specialist II to support the BPTL team of the Cancer Genomics Research (CGR) Laboratory under the Clinical Research Directorate at the Frederick National Laboratory for Cancer Research (FNLCR). The position offers an opportunity to build, implement, and sustain a robust quality framework for a large, high‑throughput biospecimen processing laboratory supporting critical translational cancer research. The incumbent will support the extension of CGR’s mature quality program to BPTL operations and staff, work closely with laboratory leadership and technical staff, and strengthen quality systems, improve standardization, support continuous process improvement, and ensure consistent compliance with established quality expectations. Key Roles / Responsibilities The BPTL team partners with intramural and extramural investigators to translate biospecimen collection workflows into practical, reliable procedures, supporting the Connect for Cancer Prevention study sponsored by the National Cancer Institute Division of Cancer Epidemiology and Genetics. BPTL receives biospecimens nationwide for processing and biobanking. Responsibilities Support the development, implementation, and continuous improvement of quality systems for a high‑throughput biospecimen processing laboratory. Extend and adapt the established quality framework used by CGR to BPTL workflows and personnel. Monitor laboratory operations to identify quality issues, process gaps, risks, and opportunities for standardization and improvement. Review laboratory records, processing documentation, quality control data, logs, and related documentation for completeness, accuracy, and compliance with procedures. Partner with laboratory leadership and staff to investigate deviations, discrepancies, non‑conformances, and other quality events, guiding corrective and preventive actions. Draft, review, revise, and maintain standard operating procedures (SOPs), forms, templates, and related quality documents. Support process development, workflow harmonization, and laboratory standardization efforts within a formalized quality program. Help establish and maintain quality metrics, document control practices, and records management processes. Conduct periodic observations of laboratory spaces and activities to ensure performance aligns with operational requirements, internal standards, and quality expectations. Collaborate closely with laboratory personnel to promote quality awareness, consistency, and accountability across specimen processing activities. Communicate clearly and effectively with team members, laboratory management, and stakeholders regarding quality findings, recommendations, and follow‑up actions. Use Microsoft Office applications (Excel, Word, PowerPoint, Outlook) for tracking, trending, reporting, document preparation, and communication. Maintain a high level of attention to detail in all aspects of quality review, documentation, and follow‑through. Basic Qualifications Bachelor’s degree in a science field (or four years of relevant experience) in accordance with CHEA or equivalent U.S. evaluation of foreign degrees. Minimum of two years of relevant quality assurance, quality control, or laboratory operations experience in a regulated, research, clinical, or high‑throughput laboratory setting. Strong quality assurance skills, including identifying, documenting, and resolving quality issues. Experience drafting, reviewing, and revising SOPs, forms, or other controlled documents. Experience supporting process improvement, development, workflow standardization, or implementation of new laboratory procedures. Strong attention to detail and ability to maintain accuracy while managing multiple priorities. Highly effective verbal and written communication skills. Strong interpersonal skills and ability to work effectively with scientific, operational, and quality‑focused teams. Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, Outlook). Ability to analyze records, organize information, and present findings clearly and accurately. Ability to maintain focus for extended periods of time. Ability to work in a laboratory environment and adhere to laboratory safety requirements. Ability to obtain and maintain a security clearance. Preferred Qualifications Prior experience supporting quality assurance activities in a biospecimen processing, biorepository, research, or high‑throughput sample processing laboratory. Demonstrated laboratory background, including experience with biological specimens and laboratory documentation. Experience building or expanding a quality program in a new laboratory environment. Familiarity with electronic laboratory notebooks (ELNs) or Laboratory Information Management Systems (LIMS). Experience implementing standardization efforts across laboratory workflows, documentation, and staff practices. Familiarity with quality management systems, document control, deviation management, CAPA, and quality metrics. Experience conducting quality observations, internal audits, or readiness assessments. Knowledge of laboratory best practices related to biospecimen processing and handling. Familiarity with applicable regulatory or quality standards relevant to biospecimen or laboratory operations. Demonstrated ability to work independently while functioning effectively in a highly collaborative team environment. Experience training or guiding laboratory staff on quality expectations and documentation practices.

JOB HAZARD

This position may involve exposure to infectious material, requiring medical clearance and immunizations. Commitment to Non‑Discrimination All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, 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. Pay And Benefits Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave, and Retirement. Pay range: $69,800.00 – $100,045.00 USD (full‑time equivalent). #J-18808-Ljbffr Frederick National Laboratory for Cancer Research