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QA Specialist – Lot Release (NCI)

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Job Number:
652624
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 QA Lot Release Supervisor, the QA Specialist will:

  • Support QA management in the establishment and implementation of quality systems in accordance with cGMP
  • Perform routine review of all documentation generated both internally and under contract in support of cGMP manufacturing including, but not limited to, QC test results, production batch records, component specifications, and environmental monitoring results to assure compliance with established quality systems and cGMP
  • Perform QA on the floor activities to monitor GMP operations
  • Perform routine release of material prior to manufacturing use
  • Support the QA team review of investigations, validation packages and process development data reviews
  • Participate in the generation and review of new and revised documents (e.g., SOPs, MBRs, test records, and other cGMP critical support documents)
  • Participate in the generation of trending key indicators (deviations, investigations, environmental monitoring excursions, CAPAs)
  • Participate in internal inspections and team meetings to facilitate the implementation of quality systems


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 educational requirement, a minimum 2 years’ related QA experience in a cGMP environment related to vaccine and biologics
  • Experience with quality systems compliant with FDA regulations for cGMP
  • Experience in the review of process batch and/or test records, deviations, CAPAs and change controls
  • Working knowledge of regulatory initiatives including ICH, USP and other regulatory intelligence sources
  • 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:

  • Intermediate professional role, responsible for delivery of professional activities while receiving a moderate level of guidance and direction
  • Focuses on providing standard professional advice and creating initial reports / analyzes for review by experienced team professionals
  • Accountable for meeting own targets which impact the immediate work area
  • Impact is generally limited to short-term team performance, occasionally on medium-term goals
  • Beginning to have more of a contributory impact on team performance
  • Requires knowledge and experience in own discipline and company policies, practices, and procedures; still acquiring higher level knowledge and skills
  • Determines a course of action based on guidelines and modifies processes and methods as required
  • Uses previous experience, analysis and investigation, to identify the most appropriate option to solve a range of differing but straightforward problems
  •  Understands and communicates fairly complex information within the specialization or recognized body of formal knowledge
  • In some instances, will need to convey information to audiences not knowledgeable of the subject matter


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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