Senior QA Compliance Specialist — Pharma

Pfizer; United States; Vor Ort; USD 83.000 - 138.000; Vollzeit

Benefits dieser Stelle

401(k) plan with Pfizer Matching Conrr

Zusammenfassung

Pfizer is seeking a Quality Engineering professional to evaluate CAPA responses, maintain QA systems, and support inspections across sites. You will manage customer quality complaints, collaborate with manufacturing sites and suppliers, and drive data-driven improvements with strong problem-solving skills.

The role requires deep experience in pharmaceutical quality systems, audits, and regulatory expectations, with a focus on cGMP adherence and process optimization.

Qualifikationen

• Experience conducting quality investigations related to pharmaceutical or medical device manufacturing processes.
• Strong understanding of Quality System functions, manufacturing and packaging processes, validations, engineering drawings, and basic statistical processes.
• Ability to apply mathematical concepts, particularly statistics and probability, to Quality Engineering tasks.
• Excellent technical writing, communication, and presentation skills.
• Proficiency in Microsoft Office, Microsoft Project, and Statistical Software.
• Experience in preparing and participating in audits and inspections.

Aufgaben

• Evaluate corrective and preventive action (CAPA) responses to audit observations for adequacy, effectiveness, and timely completion.
• Ensure Quality Assurance policies, procedures, and quality system records remain current and compliant with applicable regulatory requirements, corporate quality requirements, and site procedures.
• Prepare for and support regulatory inspections, internal audits, supplier audits, and quality assessments, ensuring timely development, implementation, and closure of resulting action plans.
• Manage, investigate, and document customer quality complaints for commercial drug products within the global complaints management system, ensuring thorough root cause analysis, timely investigations, and appropriate quality decisions.
• Collaborate with internal stakeholders, manufacturing sites, suppliers, contract manufacturers, and quality partners to ensure complaint investigations and quality records are completed in accordance with established procedures and regulatory expectations.
• Support the Supplier Quality Management Program through supplier qualification, monitoring, performance trending, issue escalation, supplier corrective action management, and quality risk assessments, as applicable.
• Assist with technical investigations involving product, process, component, and equipment-related quality issues, providing quality oversight and support for testing activities and protocol execution.
• Collect, analyze, interpret, and trend quality and operational data using appropriate statistical and risk-based methodologies to identify opportunities for continuous improvement and risk mitigation.
• Review quality system documentation and performance metrics, conduct trend analysis, and identify emerging issues requiring corrective or preventive action.
• Promote and ensure compliance with current Good Manufacturing Practices (cGMP), applicable regulatory requirements, data integrity principles, and company procedures.
• Support quality investigations, deviation management, change management, effectiveness verification activities, and continuous improvement initiatives across site quality systems.
• Prepare reports, presentations, and quality metrics to communicate findings, risks, recommendations, and quality system performance to management and stakeholders.

Kenntnisse

Quality systems

Audits & inspections

Data analysis

Statistical methods

Communication skills

Process improvements

Ausbildung

High school diploma

Associate's degree

BA/BS

MBA/MS

Tools

Microsoft Project

Statistical Software

Jobbeschreibung

Pfizer is seeking a Quality Engineering professional to evaluate CAPA responses, maintain QA systems, and support inspections across sites. You will manage customer quality complaints, collaborate with manufacturing sites and suppliers, and drive data-driven improvements with strong problem-solving skills.

The role requires deep experience in pharmaceutical quality systems, audits, and regulatory expectations, with a focus on cGMP adherence and process optimization.