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Leidos

Builds technology for defense and civil agencies

Quality Control Specialist

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeAtlanta, GA, USA$45.5k - $82.3k

About the Job

Requirements

  • A bachelor's degree and 2 years of experience, or a high school diploma and 6 years of experience, or an associate's degree and 4 years of experience.
  • Two years of experience in a related field.
  • Two years of experience supporting current Good Manufacturing Practices (cGMP) compliance.
  • Ability to work independently and as a team member.
  • Strong relationship-building and diplomacy skills.
  • Ability to handle requests from multiple groups or organizations.
  • Ability to identify errors, problems, or non-standard situations and suggest alternatives.
  • Proficiency in common software, particularly Microsoft Office, including Excel, Word, and PowerPoint.
  • Ability to lift up to 50 pounds.
  • Must have a privately owned vehicle.
  • Must be accurate, meticulous, proactive, efficient, and self-starting.

Responsibilities

  • Provide quality-control program support, including quality assurance assessments, controlled document reviews, assistance with deviation investigations, drafting audit plans and deficiency documentation, internal-control recommendations, audit and internal-control reports, advisory support for regulatory and quality alignment, and process-improvement recommendations.
  • Provide technical support to help the Government maintain a comprehensive quality-control program and ensure cGMP standards and other applicable regulatory guidelines are followed during receipt, storage, handling, transport, and distribution of pharmaceutical products.
  • Monitor and assess quality assurance activities and recommend potential program modifications or revisions to the Government.
  • Conduct audits and ad hoc assessments of SNS facilities, third-party logistics providers, and partners to support Government oversight of cGMP compliance and identify potential deficiencies; provide written findings and recommendations to Government personnel.
  • Review facility data and documentation and provide technical assessments to the Government on whether quality assurance requirements are established, controlled, and aligned with cGMP and other applicable regulatory requirements.
  • Support Government-led deviation investigations by conducting analyses, identifying potential root causes, and recommending corrective and preventive actions (CAPAs), as requested.
  • Provide technical review support for controlled documents, including Deviation Reports, CAPAs, Change Control documentation, and Validation/Qualification records; final approval authority remains with the Government.
  • Coordinate and communicate with Government officials and relevant stakeholders, including ASPR, HHS, other Federal agencies, contract partners, and members of the scientific community, as directed by the Contracting Officer or Contracting Officer’s Representative, to support resolution of quality-related matters.
  • Provide technical support to the quality-control function to ensure compliance with applicable cGMP requirements for storage and transportation of finished pharmaceuticals.
  • Develop draft audit plans and proposed cGMP audit criteria for Government review and approval.
  • Document observed deficiencies or discrepancies and recommend corrective actions to maintain cGMP and local, state, and federal compliance; Government personnel determine and direct implementation of corrective actions.
  • Analyze and evaluate internal cGMP-related controls, policies, and procedures, and provide written recommendations addressing non-compliance, control gaps, lack of controls, or operational improvement opportunities.
  • Provide drafting support for standard operating procedures and protocols, as requested by the Government.
  • Prepare draft audit and internal-control reports by collecting, analyzing, and summarizing relevant information and trends for Government review and final approval.
  • Support quality control in ensuring compliance with established internal cGMP control procedures by examining records, operating practices, and documentation.
  • Provide advisory support to help the Government maintain cGMP compliance with applicable regulatory requirements, industry standards, and program Quality System policies.
  • Recommend process improvements to enhance Quality System effectiveness and efficiency; implementation decisions remain the responsibility of the Government.

Desired Qualifications

  • Previous experience supporting a government agency.
  • Experience supporting validation or qualification of systems used in pharmaceutical storage and distribution, including reviewing protocols, test results, and validation/qualification records for alignment with cGMP requirements.

About the Company

Leidos

Builds technology for defense and civil agencies

Leidos develops technology and runs services for defense, intelligence and civilian agencies, as well as healthcare and commercial customers. It combines software and engineering work with systems integration, building secure networks and equipment used in demanding operations. Its portfolio includes medical services, energy infrastructure design and technology that supports military missions, linking specialist businesses under one parent. Customers pay through contracts for delivered systems and services, with payment tied to labor, costs or agreed project milestones. Leidos traces its roots to a company founded in 1969 and is headquartered in Reston, Virginia.

Company size
10,001+
Company stage
IPO
Headquarters
Reston, VA
Founded
1969

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