Quality Control Specialist

Leidos; Atlanta (GA); Presencial; USD 46 000 - 82 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health and Wellness programs

Income Protection

Paid Leave and Retirement

Resumo da oferta

Leidos is seeking a Quality Control Specialist to work full time onsite in Atlanta, GA. The role involves providing quality control support to maintain readiness of SNS inventory, ensuring compliance with cGMP and regulatory guidelines across receipt, storage, handling, transport, and distribution of pharmaceutical products.

The position requires local residence in Atlanta or willingness to relocate, U.S. citizenship with ability to obtain a Public Trust clearance, and collaboration with

Qualificações

• Bachelor’s degree with relevant experience (2 years minimum).
• High school diploma with 6 years of experience.
• Associates degree with 4 years of experience.
• 2 years of experience in related field.
• 2 years of experience supporting cGMP compliance.
• Ability to work independently and as part of a team.
• Proficiency with Microsoft Office: Excel, Word, and PowerPoint.

Responsabilidades

• Provide quality control program support.
• QA assessments.
• Controlled document reviews.
• Deviation investigations assist.
• Draft audit plans and deficiency documentation.
• Internal control reports and advisory support.
• Support regulatory alignment and CAPA processes.
• Coordinate with Government officials and stakeholders.

Conhecimentos

Independent worker

Team player

Problem solving

Proficiency with Microsoft Office

Formação académica

Bachelor’s degree

Associates degree

High School Diploma

Ferramentas

Microsoft Office Excel

Microsoft Word

Microsoft PowerPoint

Descrição da oferta de emprego

Leidos is seeking a Quality Control Specialist to work full time onsite in Atlanta, GA. Candidate MUST: Be local to Atlanta or be willing to relocate Be a US Citizen with the ability to obtain a Public Trust Clearance. The Strategic National Stockpile (SNS) at Leidos currently has an opening for a Quality Control Specialist in Atlanta, GA. This is an exciting opportunity to provide quality control support to assist in operating and maintaining the SNS national stockpiled inventory. In this mission, we assist in ensuring the SNS inventory is ready for deployment, providing the ability to respond 24 x 7 in an emergency. The successful candidate will provide quality control support to facilitate and maintain a high level of readiness.

Primary Responsibilities

• Provide quality control program support
• QA assessments
• Controlled document reviews
• Deviation investigations assist
• Draft audit plans and deficiency documentation
• Internal control recommendations
• Audit/internal control reports
• Advisory support for regulatory/quality alignment
• Process improvement recommendations

Provide technical support to assist the Government in maintaining a comprehensive quality control program to help ensure that cGMP standards and other applicable regulatory guidelines are adhered to during the receipt, storage, handling, transport, and distribution of pharmaceutical products.

Monitor and assess quality assurance activities and provide recommendations to the Government regarding potential program modifications or revisions, as appropriate.

Conduct audits and ad hoc assessments of SNS facilities, 3PLs, and partners to support Government oversight of cGMP compliance and to identify potential deficiencies.

Provide written findings and recommendations to Government personnel.

Review facility data and documentation and provide technical assessments to the Government regarding whether quality assurance requirements are in place, controlled and align with cGMP and other applicable regulatory requirements.

Support Government-led deviation investigations by conducting analyses, identifying potential root causes, and recommending 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 (CO) or Contracting Officer’s Representative (COR), to support resolution of quality-related matters.

Provide technical support to the QC in activities related to 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 and/or discrepancies and provide recommended corrective actions to maintain cGMP and all local, state, and federal compliance regulations.

Government personnel will determine and direct the implementation of corrective actions.

Analyze and evaluate internal cGMP-related controls, policies, and procedures, and provide written recommendations to address non-compliance, control gaps, lack of 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 ensuring compliance with established internal cGMP control procedures by examining records, operating practices, and documentation.

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.

Basic Qualifications

• Bachelor’s and 2 years
• High School Diploma and 6 years of experience
• Associates and 4 years
• 2 years of experience in related field
• 2 years of experience supporting cGMP compliance
• The ability to work both independently and as a team member
• Strong relationship-building and diplomacy skills
• Must have the ability to work handle request (s) from multiple groups/organizations
• Must be able to identify error (s), problem (s), or non-standard situations and suggest alternative (s).
• Must be proficient in common software, particularly with Microsoft Office: Excel, Word, and PowerPoint.
• Ability to lift up to 50 lbs. Most have a privately owned vehicle.
• Must possess character traits of being accurate, meticulous, proactive, efficient, self-starter, a team player.

Preferred Qualifications

• Previous experience supporting a government agency.
• Experience supporting the 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.

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At Leidos, we outthink, outbuild, and outpace the status quo — because the mission demands it.

We’re not hiring followers. We’re recruiting the ones who disrupt, provoke, and refuse to fail.

Step 10 is ancient history. We’re already at step 30 — and moving faster than anyone else dares.

Original Posting

October 23, 2026

Pay Range

Pay Range $45,500.00 - $82,250.00

Pay and Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers.

• competitive compensation
• Health and Wellness programs
• Income Protection
• Paid Leave and Retirement

More details are available here.

Commitment and Diversity

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.