Specialist QA Shop Floor

Role: QA Shop Floor Specialist responsible for 24/7 quality oversight of manufacturing, QC labs, label, and warehouse operations at a biopharmaceutical site. Objectives: ensure compliance with cGMP, support manufacturing quality, and facilitate continuous improvement. Responsibilities: conduct routine on-the-floor quality checks, interpret and triage unexpected events, review batch records, verify deviations, and act as a designated Authorized Person for release activities per GMP standards. Engage in area walkthroughs, identify quality issues, support remediation plans, and promote a quality-centric culture. Collaborate with cross-functional teams and participate in shift meetings. Requirements: Bachelor's in STEM or equivalent experience, 2+ years of cGMP experience, including 1+ years in manufacturing, with knowledge of FDA/EMA regulations in biopharma or cell therapy. Skills include decision-making, problem-solving, GxP systems (MES, SAP), and digital tools (Power Automate, Tableau). Preferred: experience with aseptic processes, quality management systems, and working in cleanroom environments. Reporting: to the Manager, QA Shop Floor. Work setup: multiple shifts (days and nights), on-site. High-value specifics: biopharma manufacturing, cGMP compliance, quality assurance in sterile and aseptic environments.