Quality Assurance and Control

At Pfizer, you will contribute to the delivery of safe and effective products to patients through your role in quality assurance and control.

Job Overview In this role, you will author, review, and approve validation master plans, protocols, and reports to ensure compliance with company standards and regulatory requirements.

Key Responsibilities

• Perform various validation activities in compliance with Good Manufacturing Practices (GMP) and Validation Master Plan (VMP) requirements.
• Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.
• Manage routine Quality systems such as Supplier Quality Management, Change Control, Quality Risk Management, Documentation, and Investigations, Annual Product Review, and coordinate testing with functional groups.
• Maintain the Site Validation Master Plan and support validation as a Subject Matter Expert during customer and regulatory audits.
• Support regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.

Requirements

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BS with at least 2+ years of experience in the pharmaceutical industry.
• Proven expertise in Good Manufacturing Practices.
• Strong working knowledge of various quality systems and processes.
• Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System.
• Excellent verbal and written communication skills.
• Ability to work independently and in a team environment.

Preferred Qualifications

• Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems.
• Experience with quality management systems like Veeva and Kneat.
• Strong analytical and problem-solving skills.
• Strong organizational and time management skills.
• Ability to mentor and guide other colleagues.
• Experience in regulatory audits and compliance.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot.
• Technical writing skills.

Physical and Mental Requirements

• Ability to perform mathematical calculations and complex data analysis.
• Sitting, lifting, standing, and bending.

Work Schedule and Travel

• Minimal travel requirements (less than 5%).
• Position requires regular onsite attendance; this position cannot be performed on a remote/telecommute basis.

Compensation and Benefits

• The annual base salary for this position ranges from $68,600.00 to $114,300.00.
• Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary.
• Comprehensive and generous benefits and programs, including a 401(k) plan with Pfizer Matching Contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits.