Quality Control Specialist

Leidos is seeking a Quality Control Specialist to work full-time onsite in Atlanta, GA. The successful candidate will provide quality control support to facilitate and maintain a high level of readiness for the Strategic National Stockpile (SNS) national stockpiled inventory.

Primary Responsibilities

• Provide quality control program support, including QA assessments, controlled document reviews, and deviation investigations
• 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
• Monitor and assess quality assurance activities and provide recommendations to the Government regarding potential program modifications or revisions
• Conduct audits and ad hoc assessments of SNS facilities, 3PLs, and partners to support Government oversight of cGMP compliance
• Review facility data and documentation and provide technical assessments to the Government regarding whether quality assurance requirements are in place
• Support Government-led deviation investigations and provide technical review support for controlled documents
• Coordinate and communicate with Government officials and relevant stakeholders to support resolution of quality-related matters
• Provide technical support to the QC in activities related to ensuring compliance with applicable cGMP requirements
• 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
• Analyze and evaluate internal cGMP-related controls, policies, and procedures, and provide written recommendations
• Prepare draft audit and internal control reports
• Support QC in ensuring compliance with established internal cGMP control procedures
• Provide advisory support to assist the Government in maintaining cGMP compliance

Basic Qualifications

• Bachelor's degree and 2 years of experience or High School Diploma and 6 years of experience or Associate's degree and 4 years of experience
• 2 years of experience in a related field
• 2 years of experience supporting cGMP compliance
• Ability to work independently and as a team member
• Strong relationship-building and diplomacy skills
• Proficient in common software, particularly Microsoft Office: Excel, Word, and PowerPoint
• Ability to lift up to 50 lbs.
• Must have a privately owned vehicle

Preferred Qualifications

• Previous experience supporting a government agency
• Experience supporting the validation or qualification of systems used in pharmaceutical storage and distribution