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DescriptionJoin a team committed to a Mission!At Leidos , we deliver innovative solutions through the efforts of our diverse and talented people who are dedicated to our customers’ success. We empower our teams, contribute to our communities, and operate sustainable. Everything we do is built on a commitment to do the right thing for our customers, our people, and our community. Our Mission, Vision, and Values (https://www.leidos.com/company/mission-vision-and-values) guide the way we do business.Your greatest work is ahead!The Administration for Strategic Preparedness and Response (ASPR) – Strategic National Stockpile (SNS) group at Leidos currently has an opening for a cGMP Quality Specialist in Atlanta, GA. This is an exciting opportunity to provide administrative support 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 cGMP Quality support to facilitate and maintain a high level of readiness.Must be able to obtain and maintain a Tier 1 National Agency Check with Inquiries (NACI) Public Trust suitability.Your Role and Primary Responsibilities
Maintain a comprehensive quality control program to ensure that cGMP standards and other regulatory guidelines are adhered to during the receipt, storage, handling, transport, and distribution of pharmaceutical products.
Monitor all quality assurance aspects of the program and recommend program revisions when necessary.
Conduct audits of SNS facilities on a regular basis to document cGMP compliance and identify deficiencies.
Review facility data and documentation to ensure all quality assurance requirements are in place, controlled, and meet cGMP and other regulatory requirements.
Investigate deviations which pose a significant risk of adversely impacting products, determine the cause of the problem, and develop corrective and preventive actions.
Maintain an interpersonal relationship with officials to resolve any issues with the quality control program.
Serve as a member of the QCU jointly responsible for ensuring compliance with applicable current go cGMPs for the storage and transportation of finished pharmaceuticals.
Develop audit plans and establish cGMP audit criteria; assess deficiencies and/or discrepancies and suggest/ implement corrective action. Report compliance deficiencies to management as required.
Analyze and evaluate internal cGMP controls, policies, and procedures. Propose recommendations and provide support for operational improvements. Assist in writing SOPs and protocols.
Prepare audit and control reports by collecting, analyzing, and summarizing information and trends.
Ensure compliance with established internal cGMP control procedures. Coordinate and conduct periodic internal audits as well as audits of contract partners.
Basic Qualifications
Required to be on-call 24 hours / 7 days a week. Must be able to respond to mission alerts within 15 minutes with a recall of 90 minutes to report to designated location. Must carry a cell phone at all times.
Bachelor’s degree with less than 2 years of experience or 6 years of experience in lieu of degree.
Must have the ability to work handle requests from multiple groups/organizations.
Must be proficient in common software, particularly with Microsoft Office: Excel, Word, and PowerPoint.
Ability to lift up to 25 lbs.
Must have reliable transportation.
Must possess character traits of being accurate, meticulous, proactive, efficient, self-starter, a team player.
Ability to obtain and maintain a Tier 1 National Agency Check with Inquiries (NACI) Public Trust suitability.
Preferred Qualifications
Previous experience supporting a government agency.
Knowledge in Microsoft Office suites to include Access.
Program's Pay Range:The program's budget for this particular position is $58,000 - $60,000 commensurate with the amount and appropriateness of experience.Pay Range:Pay Range $42,250.00 - $76,375.00The Leidos pay range for this job level is a general guideline onlyand not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.Original Posting Date:01/10/2024While subject to change based on business needs, Leidos reasonably anticipates that this job requisition will remain open for at least 3 days with an anticipated close date of no earlier than 3 days after the original posting date as listed above.REQNUMBER: R-00126080All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.
