The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases.
Reporting to the QA Manager of Compliance/Training, the QA Specialist will:
Support the maintenance and improvement to quality system processes, procedures, and GMP related activities
Assist with GEMBA walks, process audits, and/or compliance audits, as required
Write thorough, comprehensive and detailed analysis and investigations
Apply Root Cause Analysis (RCA) tools to identify systemic root causes and propose corrective actions to prevent reoccurrence
Apply RCA and Risk Management analysis to propose preventive actions and process improvements
Work directly with VCMP internal departments to ensure follow-up of quality issues
Assist in the development of solutions to moderately complex problems
Assist departments in the initiation and documentation of corrective action and/or preventive action (CAPA) plans related to GMP processes and GxP electronic systems. May also serve as the lead for CAPA execution
Facilitate cross-functional meetings with internal and external parties, as required
Write and/or implement changes to controlled documents, as needed
Assist in the development and improvement of training programs regarding all aspects of improving quality
Submit periodic status notifications (i.e. email, quality board, meetings, etc.) to leads, coordinators, and functional area approvers
Support management with the tracking of quality system metrics for adherence to organizational or department targets and escalate issues, when necessary
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
Possession of a Bachelor's degree from an accredited college/university in a scientific discipline according to the Council for Higher Education Accreditation (CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
In addition to educational requirements, a minimum of five (5) years job related experience, or a minimum of 3 years of experience in a cGMP environment
Experience in Quality, conducting investigations and/or developing/generating quality system metrics
Experience in supporting management review and/or developing/generating quality system metrics
Strong understanding of US and International regulations and requirements such as CFR, ISO, ICH, WHO, etc.
Experience with GxP Electronic Systems, e.g. TrackWise, Content Server, RAM, LIMS, etc.
Experience with implementation/improvement of quality systems
Must be able to recognize routine deviations from accepted practice
With guidance, exercise judgement within well-defined and established procedures and/or practices to determine appropriate and acceptable action(s)
Must be able to obtain and maintain a security clearance
Candidates with these desired skills will be given preferential consideration:
ASQ or other auditor training
Risk Management knowledge and/or training
Knowledge of quality control (QC) and/or biologics manufacturing
Good written and verbal communication skills to interact with all facets of the organization.
Career-level (fully competent) experienced professional able to carry out a full range of professional duties, by working independently and receiving minimal guidance
Provides professional know-how to enhance the knowledge and skill base of the organization
Accountable for meeting own target which will impact the discipline
Impact is limited to the achievement of short- to medium-term goals
Contributes to delivery of discipline / department goals through personal effort or through influence over team members
In-depth knowledge of principles and practices within a professional discipline
Uses best practices and knowledge of internal or external business issues to improve products or services and suggests variations in approach
Devises solutions based on limited information and uses past experience, evaluation, and interpretation to identify solutions or to adapt existing approaches to resolve issues; which may impact the longer term
Solves complex problems; takes a new perspective using existing solutions
Requires strong multicultural awareness to appropriately deliver messages and adapts style to differing audiences
Acts as a resource for colleagues with less experience; may direct the work of other staff members
Leidos is a global science and technology solutions leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Leidos.com. The company's diverse employees support vital missions for government and commercial customers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.