Quality Assurance Associate

We are seeking a detail-oriented and proactive Quality Assurance Associate to join our team in Augusta, GA. The ideal candidate will provide quality oversight of manufacturing areas and supporting departments such as Utilities, Warehouses, and Laboratories. This role is critical in ensuring compliance with regulatory standards and internal quality systems.

• Review batch records to ensure accuracy, completeness, and compliance, including all batch-related charts, tags, and reports are properly attached.
• Review records and disposition of Raw Materials, Intermediates, and/or finished products.
• Conduct logbook reviews and audits to ensure compliance with established procedures.
• Oversee equipment and process commissioning and qualification activities.
• Manage and oversee revalidation activities to maintain process integrity.
• Supervise computer system validation testing to ensure compliance with regulatory requirements.
• Evaluate potential SISPQ (Safety, Identity, Strength, Purity, and Quality) impact related to deviations (UADE) and support related investigations.
• Perform action verification of completed tasks associated with corrective action plans.
• Assess the effectiveness of deviation corrective actions and recommend improvements as needed.
• Revise, review, and/or approve Standard Operating Procedures (SOPs) to maintain current and compliant documentation.
• Maintain and update training modules related to the Quality Assurance function.

• Experience in quality oversight within manufacturing and supporting areas such as Utilities, Warehouses, and Laboratories.
• Strong knowledge of batch record review and documentation compliance.
• Familiarity with equipment/process commissioning, qualification, and revalidation.
• Understanding of computer system validation and testing procedures.
• Ability to evaluate deviations and their impact on product quality (SISPQ).
• Excellent attention to detail and organizational skills.
• Effective communication skills for cross-functional collaboration.
• Proficiency in reviewing and updating SOPs and training materials.