cGMP Quality Support Specialist(QC/QA)

Scope of Work

Leidos is seeking a cGMP Quality Support Specialist who will provide quality assurance support to the Center of Strategic National Stockpile. Leidos is seeking 2 (two) cGMP Quality Support Specialists in the Atlanta, GA location.

Job Title: cGMP Quality Support Specialist

The vendor shall provide services in support of the following functions. The vendor shall:

Maintain a comprehensive quality control program to ensure that cGMP standards and other

regulatory guidelines are adhered to by SNS staff, during the receipt, storage, handling, transport,

and distribution of pharmaceutical products.

1. Monitor all quality assurance aspects of the program and recommends program modifications or

revisions when necessary.

1. Conduct audits of SNS facilities, on a regular basis, to document cGMP compliance and identify

deficiencies.

1. Review facility data and documentation to ensure all quality assurance requirements are in place,

controlled, and meet cGMP and other regulatory requirements.

1. Investigate deviations which pose a significant risk of adversely impacting products, determine the

cause of the problem and develops corrective and preventive actions.

1. Maintain an interpersonal relationship with program officials, key staff within ASPR, HHS, other

Federal agencies, key contract partner representatives, members of the science-based academic

community, to resolve any issues with the quality control programs.

1. Serve as a member of the Quality Control Unit (QCU) jointly responsible for ensuring compliance

with applicable current go cGMPs for the storage and transportation of finished pharmaceuticals.

1. Develop audit plans and establish cGMP audit criteria; assess deficiencies and/or discrepancies and

suggest/implement corrective action as needed to maintain cGMP/FDA compliance. Report

compliance deficiencies to management as required.

1. Analyze and evaluate internal cGMP controls, policies and procedures. Propose recommendations

and provide support for cases of non-compliance, missing policies, lack of controls, and other

operational improvements. Assist in writing SOPs and protocols where applicable, and provides

quality control and regulatory expertise.

1. Prepare audit and control reports by collecting, analyzing, and summarizing information and trends.
2. Ensure compliance with established internal cGMP control procedures by examining records, reports,

operating practices, and documentation. Coordinate and conduct periodic internal audits as well as

audits of contract partners.

1. Assist and assure cGMP compliance with applicable regulatory requirements, industry standards, and

program Quality System policies. Make continuous improvements to the Quality Systems to execute

and implement current Good Manufacturing Practices and to increase system efficiency.

Minimum Requirements: Bachelor's Degree or equivalent plus the following:

• A minimum five (5) years of quality control/quality assurance experience in the pharmaceutical

industry providing oversight to QC/QA tasks/projects and other cGMP oversite responsibilities.

• Expertise in maintaining regulatory compliance including during PHE responses with cGMP,

inventory systems validation, FDA regulatory guidance, and 21 CFR (Parts 11, 210, 211, 600 and

800)

• Knowledge of FDA and industry standard cGMP related guidance and quality management

principles.

• Strong knowledge of relevant FDA regulatory guidance.
• Physical Demands / Surroundings - The duties of this position may require the individual to exert

some physical effort. Lifting requirements may vary dependent of the QA area assigned. Weight

is typically no more than 25 pounds.