Supplier Quality Analyst (Supplier Change Notification)
Systems AllySupplier Quality Analyst Location: Onsite – 100% Schedule: Monday–Friday, 8:00 AM–4:30 PM Job Summary We are seeking a detail-oriented Supplier Quality Analyst to support supplier quality management activities within a regulated pharmaceutical or medical device manufacturing environment. The individual will be responsible for managing supplier-related quality issues, coordinating investigations and corrective actions, reviewing supplier change notifications, maintaining supplier quality records, and monitoring supplier performance. The ideal candidate will have experience in pharmaceutical or medical device Quality Assurance, supplier quality management, and working cross-functionally with suppliers, manufacturing, purchasing, and quality teams. Key Responsibilities Coordinate the resolution of supplier-related quality issues involving purchased materials, product defects, nonconformances, and deviations. Work directly with suppliers and Manufacturing Quality Assurance teams to investigate quality concerns and implement corrective and preventive actions (CAPA). Communicate and document supplier quality issues, including nonconformances, deviations, defect reports, and material waivers. Review and evaluate Supplier Change Notifications (SCNs) to assess potential impacts on incoming materials, product quality, and manufacturing processes. Coordinate supplier change notification reviews and approvals with internal plant teams and client stakeholders to ensure timely closure. Evaluate supplier specification exceptions and acceptance requests, escalating quality concerns to management when necessary. Maintain and update supplier approvals, material specifications, specification dates, and purchasing controls in SAP. Monitor supplier performance through quality scorecards, reports, and related quality metrics. Collaborate with Purchasing, Incoming Quality Assurance (IQA), Materials Management, Manufacturing, Compliance, Validation, Technical Operations, and third-party manufacturers. Support management review activities and follow up on quality action items to ensure timely implementation and closure. Ensure supplier quality activities comply with company procedures, applicable regulations, and established quality standards. Required Qualifications Bachelor's degree in Natural Sciences, Biology, Chemistry, Engineering, or a related scientific discipline. Approximately 2–5+ years of experience in Quality Assurance or Quality-related functions within the pharmaceutical, biotechnology, or medical device industry. Experience in supplier quality management or supplier-facing quality activities. Knowledge of quality investigations, deviations, nonconformances, root cause analysis, and CAPA. Experience reviewing supplier quality documentation, change notifications, or material specifications. Understanding of GMP/cGMP requirements and regulated manufacturing quality systems. Strong written and verbal communication skills. Excellent analytical, problem-solving, organizational, and interpersonal skills. Ability to coordinate with suppliers and internal stakeholders to resolve quality issues. Preferred Qualifications Previous experience in Supplier Quality Assurance (SQA), Incoming Quality Assurance (IQA), or Pharmaceutical Manufacturing QA. Experience with Supplier Change Notifications (SCN), Supplier Corrective Action Requests (SCAR), and supplier qualification. Familiarity with SAP or other enterprise quality/material management systems. Experience preparing supplier scorecards, quality reports, and performance metrics. Knowledge of pharmaceutical raw materials, packaging components, and incoming material quality requirements. Experience working with Contract Manufacturing Organizations (CMOs), Third-Party Manufacturers (TPMs), or external suppliers. Familiarity with ISO 9001, ISO 13485, FDA regulations, and pharmaceutical GMP requirements. Work Schedule & Environment Monday through Friday, 8:00 AM–4:30 PM. 10…