Investigation Specialist I

What You Will Achieve

In this role, you will:

• Lead and author GMP investigations within Pfizer quality systems for manufacturing deviations, product quality excursions, equipment and facility events, and compliance-related observations.
• Conduct thorough fact-finding, data collection, and technical assessments utilizing manufacturing records, process data, laboratory data, audit trails, equipment histories, and enterprise systems.
• Facilitate cross-functional investigation teams to identify root causes using structured problem-solving methodologies and quality risk management principles.
• Partner with Manufacturing, Quality Assurance, Process Development, Engineering, Validation, and Analytical teams to determine event impact, product disposition requirements, and corrective/preventive actions.
• Drive investigations to completion while ensuring quality, regulatory compliance, and adherence to established timelines.
• Evaluate investigation trends and support continuous improvement initiatives aimed at reducing repeat events and improving manufacturing robustness.
• Support internal and external audits, regulatory inspections, and quality system assessments as required.
• Contribute to additional quality and compliance initiatives, including audit responses, CAPA effectiveness evaluations, risk assessments, and procedure development.

Qualifications

Must Have

• Bachelor's degree with 0 to 2 years of relevant experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
• Strong technical writing and documentation skills with demonstrated ability to author complex GMP records
• Experience in a GMP biotechnology manufacturing or laboratory environment
• Ability to analyze technical data, identify trends, and present clear, evidence-based conclusions.
• Excellent organizational and project management skills with the ability to independently manage multiple priorities and deadlines.

Nice to Have

• Commitment to continuous improvement and operational excellence
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.
• Experience authoring and leading cGMP manufacturing investigations, deviations, CAPAs, and quality event records.
• Working knowledge of biologics manufacturing processes including cell culture, purification, filtration, formulation, and supporting utilities.
• Familiarity with quality risk management and root cause analysis tools such as Fishbone, 5-Why, FMEA, Fault Tree Analysis, or similar methodologies.
• Experience utilizing manufacturing and quality systems including DeltaV, SAP, Microsoft Dynamics, LIMS, electronic batch records, document management systems, and data historian platforms.
• Experience supporting regulatory inspections, internal audits, and inspection readiness activities.

Physical/Mental Requirements

• Ability to perform mathematical calculations and complex data analysis
• Ability to gown into/out of manufacturing clean rooms