Quality Control Specialist

Leidos•Atlanta, GA

17d•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 for operating and maintaining the SNS national stockpiled inventory and helps ensure it is ready for emergency deployment 24 hours a day, 7 days a week. The successful candidate will support the Government in maintaining a comprehensive quality control program and a high level of readiness, with a focus on cGMP compliance and other applicable regulatory requirements for pharmaceutical products throughout receipt, storage, handling, transportation, and distribution. The candidate must be local to Atlanta or willing to relocate, be a U.S. citizen, and be able to obtain a Public Trust Clearance. The specialist conducts assessments and audits, reviews controlled documents and facility records, supports deviation investigations, and prepares draft audit plans, findings, reports, and recommendations for Government review. The role also provides technical and advisory support on cGMP compliance, internal controls, Quality System policies, and process improvement. Government personnel retain final approval authority and responsibility for implementation decisions, including corrective actions.

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 Office applications Excel, Word, and PowerPoint.
Ability to lift up to 50 pounds.
Must have a privately owned vehicle.
Must be accurate, meticulous, proactive, efficient, a self-starter, and a team player.
Must be local to Atlanta or willing to relocate.
Must be a U.S. citizen and able to obtain a Public Trust Clearance.

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/qualification records for alignment with cGMP requirements.

Responsibilities

Provide quality control program support, including QA assessments, controlled-document reviews, deviation-investigation assistance, audit-plan and deficiency-documentation drafts, internal-control recommendations, reports, advisory support, and process-improvement recommendations.
Provide technical support to the Government in maintaining a comprehensive quality control program and adherence to cGMP standards and other applicable regulatory guidelines for 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 (3PLs), and partners to support Government oversight of cGMP compliance and identify potential deficiencies.
Document audit findings and provide written findings and recommendations to Government personnel.
Review facility data and documentation and assess whether quality assurance requirements are in place, 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.
Technically review controlled documents, including Deviation Reports, CAPAs, Change Control documentation, and Validation/Qualification records; final approval 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 support resolution of quality-related matters.
Provide technical support to the QC in activities related to cGMP compliance 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 applicable local, state, and federal compliance; Government personnel determine and direct implementation.
Analyze and evaluate internal cGMP-related controls, policies, and procedures, and provide written recommendations addressing non-compliance, control gaps, missing controls, or operational improvement opportunities.
Provide drafting support for SOPs 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 QC in examining records, operating practices, and documentation to help ensure compliance with established internal cGMP control procedures.
Provide advisory support to assist the Government in maintaining 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.