QA Manager II

Location
Rockville, MD, USA
Posted
Sep 14, 2019
Ref
req679
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
The Leidos Biomedical Research, Inc.'s (LBR) staff of scientific, technical, and support professionals conduct basic and applied research in cancer and AIDS. One of LBR's primary responsibilities is to operate the Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center focused on cancer and AIDS research. The LBR Biospecimen Research Group (BRG) based in Rockville, MD supports work being performed for the National Cancer Institute's Center for Strategic Scientific Initiatives (CSSI) specifically the Clinical Proteomic Tumor Analysis Consortium (CPTAC) which is a comprehensive and coordinated effort to accelerate the understanding of the molecular basis of cancer with the primary goal to improve the ability to diagnose, treat and prevent cancer by systematically identifying proteins that derive from alterations in cancer genomes and related biological processes, and provide this data with accompanying assays and protocols to the public.

KEY ROLES/RESPONSIBILITIES

The Quality Manager II will:
  • Support the Program by managing Quality schedules and resources, and establishing/improving QA/QC systems
  • Conduct quality reviews/audits, tracking, and metrics analysis
  • Work closely with the project team and be responsive to team's requests
  • Work in a manner that enables an integrated, team-based, quality-management approach
  • Review/approve Standard Operating Procedures (SOPs) and protocols
  • Play an integral role in a multidisciplinary project team effort leading the discovery of proteomic and genomic signatures of cancer
  • Provide quality expertise
  • Draft and review audits, QC plans and other quality related reports
  • Manage development and analysis of quality metrics pertinent to product and service quality
  • Manage quality systems including: change control/deviation reporting, training and document control
  • Represent the Quality department at project team meetings and during interactions with clients/subcontractors
  • Conduct scientific evaluation of technical data to ensure product quality objectives are consistently met
  • Report on quality team status and metrics
  • Travel both domestic and international approximately 5% of the time

BASIC QUALIFICATIONS
  • Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/scientific discipline (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the educational requirements, a minimum of six (6) years of experience in relevant experience in quality assurance for life sciences, including two (2) years of experience in a leadership capacity
  • Knowledge of quality assurance concepts and practices and managing basic quality systems (e.g., change control, deviation reporting, training and document control, metrics analysis)
  • Knowledge of Quality Control for molecular analysis in support of genomics and/or proteomics research
  • Knowledge of Food and Drug Administration (FDA) regulations, including Good Clinical Practice (GCPs)
  • Ability to independently conduct audits and quality reviews to drive evaluation and improvement in logistical and operational protocols
  • Proficiency in Microsoft Office® inclusive of Word, Excel, Access and PowerPoint and principles of timelines within Microsoft® Project
  • Must be able to obtain and maintain a security clearance
  • Ability to travel approximately 5%

PREFERRED QUALIFICATIONS
  • Ability to conduct risk assessments, oversee investigations and lead audits
  • Expertise in a variety of disciplines tangential to the science
  • An understanding of the technical and programmatic areas of biobanking human specimens
  • Knowledge of best practices in biobanking operations and biobanking data standards
  • Experience in biospecimen sciences research with knowledge of pre-analytical influence

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