QA Inspector II

Role: QA Inspector II overseeing daily inspection activities for finished products and sub-assemblies in a biopharma manufacturing setting. Objectives: ensure quality compliance of biologic drug products through thorough inspection processes. Responsibilities: perform visual and in-process inspections, verify components against engineering records, review batch records, prepare documentation, initiate non-conformance reports, support records retention, and assist in investigations for deviations. Requirements: High School Diploma or GED; 3-5 years of experience in quality inspection within a controlled environment; knowledge of ISO 9001, ISO 13485, 21CFR820 standards; ability to interpret engineering drawings and documentation; proficiency with QA software; strong communication, organizational, and attention-to-detail skills. Preferred: laboratory or manufacturing experience in biopharma, familiarity with AQL Inspection Plans. High-Value: biologics manufacturing, quality assurance, batch record review, deviation investigations, compliance with GxP and regulatory standards. Collaboration: may interact with multiple departments; reports to QA Supervisor or QA Manager. Work setup: Role specifics on location modality and travel are not provided.