Quality Control Specialist

Leidos•Atlanta, GA

9d•$45,500 - $82,250•Onsite

About The Position

Leidos is seeking a full-time, onsite Quality Control Specialist in Atlanta, Georgia, to support the Strategic National Stockpile (SNS). The role provides quality control support to help operate and maintain the national stockpiled inventory and ensure it is ready for deployment, including in emergencies. The specialist supports a comprehensive quality control program and helps the Government maintain compliance with current Good Manufacturing Practice (cGMP) standards and other applicable regulatory requirements for pharmaceutical products throughout receipt, storage, handling, transportation, and distribution. The specialist provides technical assessments, audit and internal-control support, controlled-document review, deviation-investigation assistance, and recommendations concerning corrective actions and process improvements. They work with Government officials and relevant stakeholders as directed by the Contracting Officer or Contracting Officer’s Representative. Government personnel retain final approval and implementation authority for quality decisions and corrective actions. The position is onsite in Atlanta. Candidates must be local to Atlanta or willing to relocate, be U.S. citizens able to obtain a Public Trust Clearance, and have a privately owned vehicle. The role requires the ability to lift up to 50 pounds. The listed pay range is $45,500 to $82,250.

Requirements

Bachelor’s degree and 2 years of experience, or a high school diploma and 6 years of experience, or an associate degree and 4 years of experience.
Two years of experience in a related field.
Two years of experience supporting 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 with common software, particularly Microsoft Excel, Word, and PowerPoint.
Ability to lift up to 50 pounds.
Must have a privately owned vehicle.
Must be a U.S. citizen and able to obtain a Public Trust Clearance.
Must be local to Atlanta or willing to relocate.
Must be accurate, meticulous, proactive, efficient, a self-starter, and a team player.

Nice To Haves

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 or qualification records for alignment with cGMP requirements.

Responsibilities

Provide quality control program support, including quality assurance assessments, controlled-document reviews, deviation-investigation assistance, audit-plan and deficiency-document drafting, internal-control recommendations, reports, regulatory and quality advisory support, and process-improvement recommendations.
Provide technical support to the Government in maintaining a quality control program that promotes adherence to cGMP standards and applicable regulations during pharmaceutical product receipt, storage, handling, transportation, and distribution.
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; identify potential cGMP deficiencies; and provide written findings and recommendations to Government personnel.
Review facility data and documentation and provide technical assessments of whether quality assurance requirements are established, controlled, and aligned with cGMP and other applicable regulatory requirements.
Support Government-led deviation investigations by analyzing issues, 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 CO or COR, to help resolve quality-related matters.
Provide technical support for activities ensuring compliance with applicable cGMP requirements for the 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 applicable local, state, and federal compliance; Government personnel determine and direct corrective-action implementation.
Analyze and evaluate internal cGMP-related controls, policies, and procedures; provide written recommendations addressing non-compliance, control gaps, missing controls, or operational improvement opportunities; and draft SOPs and protocols as requested.
Prepare draft audit and internal-control reports by collecting, analyzing, and summarizing relevant information and trends for Government review and final approval.
Examine records, operating practices, and documentation to support compliance with established internal cGMP control procedures.
Provide advisory support on cGMP compliance with applicable regulations, industry standards, and program Quality System policies, and recommend improvements to Quality System effectiveness and efficiency.