Description

The Government Assistant Secretary for Preparedness and Response (ASPR) - Strategic National Stockpile (SNS) Group currently has an opening for a cGMP Quality Support Specialist to work in our Atlanta office.

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 develops 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 (Minimal requirements):

• Bachelors with less 2 years of experience or 6 years of experience in lieu of degree.

• Required to be on-call 24 hour/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.

• Must have the ability to work handle request(s) 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 possess character traits of being accurate, meticulous, proactive, efficient, self-starter, a team player.

Preferred Qualifications:

• Knowledge in government processes.

• Knowledge in Microsoft Office suite to include Access.

NOTE: The program’s base pay range for this position is $48,000 – $55,000 but is not a guarantee. Please see statement below regarding other factors considered.

The Leidos pay range for this job level is a general guideline only and 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.