Senior QA Validation Associate

Rangam International • Sanford, NC

79d • $80,300 - $133,900

About The Position

Use Your Power for Purpose Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

Requirements

• Applicant must have a Bachelor's degree with at least 2 years of experience; OR a Master's degree with 0+ years of experience; or an Associate's degree with 6 years of experience; OR a High school diploma (or equivalent) and 8 years of relevant experience.
• Proven expertise in current Good Manufacturing Practices and relevant GxP regulations and standards.
• Experience with regulatory compliance and documentation.
• Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System.
• Strong working knowledge in Microsoft Office Suite.

Nice To Haves

• Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems.
• Experience in regulatory audits and compliance.
• Experience with sterile products and medical devices.

Responsibilities

• Review validation documentation for the site, ensuring adherence to regulatory agency requirements, ICH Guidelines, and Pfizer standards, policies and values.
• Plan and execute projects with support; suggest improvements and conduct continuous improvement activities.
• Represent QA Validation in cross-departmental/cross-site meetings.
• Maintain oversight of quality and compliance requirements throughout the product life cycle from design through BLA submission.
• Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
• Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.
• Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution.
• Conduct statistical analysis of testing results and process anomalies and provide high-level data analysis support for Quality Investigations.
• Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holiday and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree