Shire Jobs

Job Title: Quality Assurance (QA) Specialist Reports to: Quality Management Systems (QMS) Manager Classification: Full Time, Exempt Work Location: Onsite - Rochester, MN POSITION SUMMARY: The Quality Assurance (QA) Specialist is responsible for implementing and supporting the Quality Management System (QMS) in accordance with company policies and procedures. PRINCIPAL RESPONSIBILITIES: Write, revise, review, and approve site procedures and policies. Review and approve investigations and associated CAPAs, Change Controls and nonconformance. Participates in regulatory agency (i.e., FDA, etc.) inspections. Investigate or serve as GMP QA approver for customer complaints, deviations / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented. Assemble, analyze, and report QA data (metrics) to ensure regulatory compliance, identify trends and to identify areas of improvement. Review Batch Records and provide final product disposition. Conducts internal audits of GMP Quality Systems and sub systems. Aide in assessing risk during Supplier Qualifications or Material Assessments. Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications. Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications by conducting incoming material disposition. Reviews and assesses in-house solution preparation and external material testing. Document Control, Training, Quality Systems back-up, and key trainer for conducting GMP training. May assist in conducting Supplier Qualification and reviews. Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Performs other duties as assigned