Hiring: Quality Assurance Manager Company: Aruna Bio, Inc. Location: Athens, GA Job Posted Time: 2026-09-10 13:30:34 Employment Type: Contract Target Skills & Keywords : GCP, Product Management, Quality Assurance About the job Experience: •3 years of experience in Quality Assurance within regulated biopharmaceutical, biotechnology, or pharmaceutical environments. Experience with cell therapy, gene therapy, or exosome/biologic modalities strongly preferred. Required Skills: •·        Review executed batch records and associated QC documentation for accuracy, completeness, and compliance with approved procedures. •·        Support and ensure full traceability from raw materials through manufacturing execution and final product release. •·        Oversee and/or support document control processes for Standard Operating Procedures (SOPs), batch records, forms, templates, and controlled records. •·        Work with team to mature the Quality Management System (QMS). •·        Analyze and document environmental monitoring data. •·        Oversee corrective and preventive actions (CAPAs), laboratory investigations, and deviations related to bioprocessing, OOS/OOT results, equipment failures, environmental excursions, and documentation errors. •·        Manage and approve change control requests related to materials, analytical methods, equipment, processes, or documents, ensuring all changes are risk-assessed and processed in accordance with the QMS. •·        Assist in the qualification of new suppliers and vendors; review supplier documentation, audit reports, and ongoing performance evaluations. Serve as primary QA point of contact for contract suppliers and testing vendors, including drafting and maintaining Quality Agreements. Qualifications: •·        Bachelor’s degree in Life Sciences or a related scientific discipline required. •·        Minimum of 3 years of experience in Quality Assurance within regulated biopharmaceutical, biotechnology, or pharmaceutical environments. Experience with cell therapy, gene therapy, or exosome/biologic modalities strongly preferred. •·        Direct experience supporting GMP manufacturing and clinical-stage programs is highly desirable, including batch record review, deviation management, CAPA, change control, and document control. •·        Strong understanding of data integrity principles (ALCOA+). •·        Strong working knowledge of GMP, GCP, GLP, and FDA regulations. •·        Excellent written and verbal communication skills. •·        Ability to exercise sound judgment, maintain independence, and appropriately escalate quality concerns. •·        Ability to operate in a lean, cross-functional organization where this role may absorb responsibilities typically split across QA, QC, and Regulatory functions at larger companies. •·        ASQ Certified Quality Auditor (CQA) or RAC certification a plus. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!