Investigation Specialist I

Role: GMP Investigator within Pfizer manufacturing quality assurance, responsible for leading and authoring investigations into manufacturing deviations, product quality issues, and compliance events. Key duties include conducting detailed fact-finding through data analysis of manufacturing records, laboratory data, and audit trails; facilitating cross-functional teams to identify root causes using structured problem-solving and risk management tools; and coordinating with Manufacturing, Quality Assurance, and Engineering to evaluate impacts, determine product disposition, and implement corrective/preventive actions. Responsibilities extend to supporting audits, regulatory inspections, and continuous quality improvement initiatives. Qualifications: Bachelor's degree with 0-2 years or an equivalent combination of education and experience; strong GMP technical writing skills; experience in biotech manufacturing or laboratories; ability to analyze technical data and trends; excellent project management skills. Preferred skills include familiarity with biologics processes (cell culture, purification), quality risk management tools (FMEA, Fishbone, 5-Why), and manufacturing systems (SAP, LIMS, DeltaV). Experience supporting regulatory inspections and process improvements is advantageous. The role is based on-premises, with physical requirements including gowning into clean rooms. High-value specifics: focus on biologics, GMP compliance, investigations, and product quality assurance within manufacturing operations.