Quality Assurance Manager II, CGR

Job ID: req3895
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: Rockville: 9615 MedCtrDr
Location: 9615 Medical Center Drive, Rockville, MD 20850 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 Cancer Genomics Research Laboratory (CGR) investigates the contribution of germline and somatic genetic variation to cancer susceptibility and outcomes in support of the NCI's Division of Cancer Epidemiology and Genetics (DCEG), the world’s most comprehensive cancer epidemiology research group. CGR is located at the NCI-Shady Grove campus in Rockville, MD and operated by Leidos Biomedical Research, Inc. We care deeply about discovering the genetic and environmental determinants of cancer, and new approaches to cancer prevention, through our contributions to the molecular, genetic, and epidemiologic research of the 70 investigators in DCEG. Working in concert with epidemiologists, biostatisticians and basic research scientists in DCEG’s intramural research program, CGR provides the capacity to conduct genome-wide discovery studies and targeted regional approaches to identify the heritable determinants of various forms of cancer. This includes the design and analysis of high throughput studies using various types of “–omics” technologies such as array- and sequence-based genome-wide association studies, studies of tumor characteristics using integrated genomic data analysis, and molecular epidemiologic studies based on novel assays focused on the metabolome and microbiome. 

KEY ROLES/RESPONSIBILITIES

The Cancer Genomics Research (CGR) laboratory is a fast-paced, high throughput organization that supports histology, molecular and digital pathology, nucleic acid extraction, sample staging, genotyping, sequencing, and analysis for genetic and epidemiologic studies for the investigators within DCEG. We are recruiting for a Quality Assurance Manager II to design, implement, maintain and improve all aspects of the CGR quality management program. Reporting to the CGR Director of Operations, the successful candidate will work seamlessly across all areas of the organization and will be responsible for:

• Directly supervise a team of two senior quality assurance specialists.
• Maintain the CGR document control system, ensuring the effective management, control, and availability of standard operating protocols utilized by all functions of the organization.
• Working with relevant management, maintain a robust training program including identification of appropriate training roles, methods for competency assessment, and records management.
• Working with CGR logistics, administration and laboratory management, support reagent, materials and equipment management programs.
• Maintain cold storage systems and monitoring in conjunction with vendor and laboratory management.
• Work with laboratory management and staff to ensure proper safety protocols, training and waste management.
• Lead all internal audit activities, including collaboration with laboratory management for resolution of audit findings and remediation activities.
• As necessary, suggest and employ external auditing approaches to meet CGR and DCEG research aims.
• Maintain and improve upon existing deviation/CAPA program. Identify risk and evaluate deficiencies while working alongside area management and staff.
• Serve as an advocate for quality and good laboratory practices in a highly performant and high throughput laboratory.
• Practice and advocate safe work habits, including complying with all safety, health and environmental rules and regulations. Work includes potential exposure to OPIM (BSL2) and hazardous chemical waste.
• Other duties as assigned.

BASIC QUALIFICATIONS

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

• Possession of Bachelor’s degree in a field related to biomedical research 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 six (6) years of experience in quality assurance, quality control and/or molecular biology including a minimum of four (4) years in a managerial role
• Accurate and strong verbal and written communication skills with impeccable attention to detail.
• Computer literacy (Microsoft Office products, general computer proficiency) with demonstrated skills. in document management.
• Ability to obtain and maintain a security clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Familiarity with CLIA, GLP, ISO regulations ideal. Exposure to concepts of Six Sigma, Lean and BPI a plus.
• Proven ability to influence with or without authority.
• Experience in utilization of LIMS for process tracking.
• Experience with data analysis and visualization tools such as Excel, Tableau, Palantir.
• Ability to facilitate consensus among teams and groups with diverse perspectives.
• Ability to prioritize and multi-task.

JOB HAZARDS

• 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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