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cGMP Quality Support Specialist

cGMP Quality Support Specialist

Allyon, Inc.Atlanta, GA, United States
3 days ago
Job type
  • Full-time
Job description

cGMP Quality Support Specialist

Job Details

Location : Atlanta, GA

Position Contact : Tyler Pettway

Job Number : 32074

Job Posted Date : 8 / 27 / 2025

Job Description

Job Title :

cGMP Quality Support Specialist

Location : Atlanta, GA

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.

Duties & Responsibilities :

  • 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.
  • Monitor all quality assurance aspects of the program and recommends program modifications or 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 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.
  • 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.
  • 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.
  • 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.
  • Prepare audit and control reports by collecting, analyzing, and summarizing information and trends.
  • 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.
  • 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.
  • Pay Range : $20 / hr - $21 / hr

    Summary :

    Allyon is a certified woman-owned small business dedicated to empowering cleared IT professionals to reach their career goals and building high-performance teams for our federal government clients nationwide. With over 15 years of experience supporting the federal government, we've proudly helped professionals like you achieve their career goals across all areas of IT. Apply today and become part of our mission to support the nation's most critical technology, infrastructure, and cybersecurity initiatives. Together, we can drive innovation and make a difference where it matters most!

    What we offer :

  • Competitive pay and benefits
  • 401k eligibility after 6 months including company match
  • Allyon, Inc. is an equal employment opportunities (EEO) employer and terms of employment are without regard to race, color, religion, sex, national origin, age, disability or genetics. Allyon, Inc. complies with applicable state and local laws governing nondiscrimination in employment. This policy applies to all terms and conditions of employment.

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