Quality Assurance Specialist 3, Floor Support

Role: Quality Assurance Specialist III providing real-time QA support in classified manufacturing environments, primarily in cGMP-compliant aseptic drug production. Objectives include ensuring manufacturing compliance, documentation accuracy, and issue resolution within sterile, validated processes. Responsibilities encompass reviewing batch records, environmental data, and facility alarms; supporting deviation investigations, CAPAs, and audits; and maintaining strict gowning and cleanroom protocols. Requirements: Bachelor's in an applied science or equivalent; 5+ years of QA experience in GMP manufacturing, with aseptic manufacturing preferred. Skills include thorough knowledge of cGMP regulations, strong documentation and analytical abilities, and effective cross-functional communication. High-Value: GMP aseptic drug manufacturing, cleanroom operations, documentation review, deviation management, internal audits. Work setup: exclusively onsite; full gowning and cleanroom presence required; not eligible for remote or hybrid arrangements.