QA Specialist – Lot Release (NCI)

Unlock Employer FREDERICK, MD Live
Leidos is looking for QA Specialist – Lot Release (NCI) in FREDERICK, MD. This local job opportunity with ID 11118102 is live since 07/21/2018.
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, Lot Release, 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 education requirement, a minimum five (5) 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 test records, deviations, CAPAs and change controls
  • Experience in performing routine internal audits
  • 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 materials

Expected Competencies:

  • 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


Employer Overview:
Employer 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, Employer 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 Employer with Lockheed Martin's Information Systems & Global Solutions business (IS&GS). For more information, visit www.Employer.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. Employer will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Employer is an equal opportunity employer/disability/vet. read more

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