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QA Specialist - Compliance (NCI)

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Job Number:
652351
Job Category:
Process Improvement / Quality Assurance
Location:
FREDERICK, MD US
Schedule:
Full-time
Travel:
None
Shift:
Day Job
Potential for Teleworking:
No
Clearance Level Must Currently Possess:
None
Clearance Level Must Be Able to Obtain:
Public Trust
Description:

PROGRAM DESCRIPTION

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.

KEY ROLES/RESPONSIBILITIES

Reporting to the Supervisor of QA Compliance, the QA Specialist - Compliance will:

  • Participate in the oversight and management of internal audits, supplier management activities, and client audits
  • Lead internal and external audits of the various quality elements to ensure compliance to regulatory commitments and requirements, industry best practices and guidance
  • Lead and facilitate special projects associated with audit readiness and process improvements
  • Demonstrate ability to document and present data, information, status, and solutions through documentation, flowcharts, layouts, diagrams, charts, and reports
  • Review, track and/or trend routine quality data, Report adverse trends to compliance management with remediation plan
  • Independently write and implement controlled documents (i.e., SOPs, Policies, Protocols) which may entail significant system changes
  • Provide cross-departmental support to resolve quality related issues as they relate to observations, deviations, non-conformances, corrective actions, and/or preventive actions
  • Perform final quality review/assessment for validation documentation, GMP documentation, change controls, deviations, RCA’s, CAPA’s, and internal procedures
  • Facilitate Material Review Board meetings in the absence of Compliance Management
  • Train and mentor junior staff on interdepartmental processes
  • Train and mentor VCMP staff in activities critical to the success of the compliance department
  • Provide reports on a routine basis to QA management
  • Support QA management in the establishment and implementation of quality systems in accordance with cGMP


Qualifications:

BASIC QUALIFICATIONS

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 or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirements, a minimum of 8 years of progressively responsible job-related experience or 5 years progressively responsible job-related experience in a GMP environment
  • Experience with quality systems compliant with FDA regulations for cGMP
  • Experience in the review of test records, deviations, CAPAs, and change controls
  • Experience in performing routine internal and external audits
  • Ability to clearly summarize and communicate compliance issues to staff
  • Working knowledge of Microsoft Office
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Combination of QA and QC or manufacturing experience
  • Working knowledge of quality systems and TrackWise
  • Experience with the GMP manufacture of Phase I/II clinical material

Expected Competencies:

  • Advanced level professional providing professional input to complex assignments / projects, providing direction to more junior professionals while working independently receiving guidance in only the most complex situations
  • Exercises judgment in the evaluation, selection, and adaptation of both standard and complex techniques and procedures
  • Accountable for meeting own target which will impact the discipline
  • Impact is limited to the achievement of medium-term goals
  • Develops and manages operational initiatives to deliver tactical results
  • Advanced knowledge in the specialized field and broad knowledge of several related disciplines within a function
  • Understands the interrelationships of different disciplines, directs the application of existing principles and guides development of new policies and ideas
  • Implementation of solutions often require a longer-term view, based on limited information, and take into consideration multiple perspectives and future implications
  • Solves complex problems; takes a broad perspective to identify solutions
  • Adapts style and uses persuasion in delivering messages on complex issues where audience perspectives will be divergent
  • Acts as a resource for colleagues with less experience; may direct the work of other staff members


Leidos Overview:
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. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.
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