MQ Downstream Specialist

Responsibilities

• Evaluate and review clinical and commercial drug batches to ensure quality and compliance
• Ensure product and process documents meet established specifications through sampling and statistical process control
• Identify and address deviations from manufacturing and packaging standards
• Approve investigations and oversee change control activities to maintain compliance
• Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards
• Maintain inspection readiness and support regulatory and customer inspections
• Assist manufacturing and packaging staff in real-time compliance error detection and resolution

Requirements

• Bachelor's degree with experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma with 6 years of relevant experience
• Experience in the pharmaceutical industry and Quality administered systems
• Sound knowledge of current Good Manufacturing Practices (GxP)
• Effective written and oral communication skills
• Ability to work effectively in both individual and interdepartmental team environments

Preferred Qualifications

• Experience working at a manufacturing site
• Experience managing and writing deviations
• Experience in production batch record review and Enterprise Resource Planning (ERP) systems
• Proficiency in investigation of non-conformance, root cause analysis, and change control management
• Strong problem-solving, time management, and multitasking abilities
• Experience using generative AI tools to support problem solving

About the Company

Pfizer is a global leader in the pharmaceutical industry, dedicated to improving patient outcomes through science and innovation. We foster a culture of individual ownership and commitment to quality, working to unearth new therapies that make the world a healthier place.