QA Specialist II, NCI CONNECT STUDY

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 BioProcessing and Trial Logistics team of the Cancer Genomics Research (CGR) Laboratory under the Clinical Research Directorate at the Frederick National Laboratory for Cancer Research (FNLCR). This position offers an exciting opportunity for a quality-focused laboratory professional to help build, implement, and sustain a robust quality framework for a large, high-throughput biospecimen processing laboratory supporting critical translational cancer research efforts. The incumbent will play a key role in extending the mature quality program of CGR to BPTL operations and staff. This individual will work closely with all levels of laboratory leadership and technical staff to strengthen quality systems, improve standardization, support continuous process improvement, and ensure that biospecimen handling and laboratory workflows consistently meet established quality expectations. This is an ideal opportunity for a candidate with a strong laboratory background, demonstrated quality assurance expertise, and well-developed communication skills who thrives in a fast-paced, mission-driven environment. KEY ROLES/RESPONSIBILITIES The BPTL group partners with intramural and extramural investigators to translate biospecimen collection workflows into practical and reliable collection, processing, and storage procedures. These efforts produce high-quality, well-annotated specimens that support both their primary research purpose and broader bioresource collections for future research. Primary operations at BPTL support the Connect for Cancer Prevention study sponsored by the National Cancer Institute Division of Cancer Epidemiology and Genetics. BPTL receives Connect biospecimens from collection centers throughout the country for processing and subsequent biobanking. As a Quality Assurance Specialist II, the incumbent will play an essential role in developing and supporting quality systems for BPTL laboratory operations. Core responsibilities include: Supporting the development, implementation, and continuous improvement of quality systems for a high-throughput biospecimen processing laboratory Extending and adapting the established quality framework used by the Cancer Genomics Research Laboratory to BPTL workflows and personnel Monitoring laboratory operations to identify quality issues, process gaps, risks, and opportunities for standardization and improvement Reviewing laboratory records, processing documentation, quality control data, logs, and related documentation for completeness, accuracy, and compliance with established procedures Partnering with laboratory leadership and staff to investigate deviations, discrepancies, nonconformances, and other quality events, and helping guide appropriate corrective and preventive actions Drafting, reviewing, revising, and maintaining standard operating procedures (SOPs), forms, templates, and related quality documents Supporting process development, workflow harmonization, and laboratory standardization efforts in an environment building a formalized quality program Helping establish and maintain quality metrics, document control practices, and records management processes Conducting periodic observations of laboratory spaces and activities to ensure performance aligns with operational requirements, internal standards, and applicable quality expectations Collaborating closely with laboratory personnel to promote quality awareness, consistency, and accountability across specimen processing activities Communicating clearly and effectively with team members, laboratory management, and internal stakeholders regarding quality findings, recommendations, and follow-up actions Using Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook, for tracking, trending, reporting, document preparation, and communication Maintaining a high level of attention to detail in all aspects of quality review, documentation, and follow-through 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 in a science field (preferably related to biomedical research) 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 two (2) years of relevant quality assurance, quality control, or laboratory operations experience in a regulated, research, clinical, or high-throughput laboratory setting is required Demonstrated strong quality assurance skills, including identifying, documenting, and helping resolve quality issues Experience drafting, reviewing, and revising SOPs, forms, or other controlled documents Experience supporting process improvement, process 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, including Excel, Word, PowerPoint, and 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 Candidates with these desired skills will be given preferential consideration: Previous experience supporting quality assurance activities in a biospecimen processing, biorepository, research, or high-throughput sample processing laboratory Demonstrated laboratory background, including experience working with biological specimens and laboratory documentation Experience helping build or expand a quality program into a new laboratory environment Previous experience 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 also functioning effectively in a highly collaborative team environment Experience training or guiding laboratory staff on quality expectations and documentation practices JOB HAZARD This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations