QA Validation Specialist III - GMP & Validation Expert

Pfizer; Andover (MA); On-site; USD 83,000 - 138,000; Full time

Benefits offered by this job

401(k) with Pfizer Matching Contrib.

Pfizer Retirement Savings Contribution

Paid vacation and holidays

Health, dental, vision benefits

Job summary

Pfizer in Andover, MA is seeking a Quality Assurance professional to oversee the validation program, review validation documents, and support change controls. The role requires blending regulatory knowledge with hands-on validation activities and strong communication with project teams.

Ideal candidates have a solid grasp of GMP guidance and experience in a matrixed environment, with proficiency in enterprise systems like Veeva and Pfizer repositories.

Qualifications

• Bachelor’s degree with 4+ years of experience; OR a master’s with 2+ years; OR PhD with 0+ years; OR associate’s with 8+ years; OR high school and 10+ years.
• Strong understanding of validation principles and practices.
• Experience with regulatory requirements and guidelines for validation.
• Proficiency in project management and resource planning.
• Ability to work independently and make decisions in ambiguous situations.
• Excellent communication and interpersonal skills.
• Proficiency in computerized systems and software applications.

Responsibilities

• Serve as Quality Assurance oversight for the validation program at the Andover, MA Pfizer site.
• Review and approve validation documents, change controls, and related testing documents.
• Provide support to project teams on compliance and technical issues related to validation.
• Review and approve investigations, commitments, and procedures as they relate to validation.
• Assist in continuous improvement and ensure inspection readiness.
• Utilize Enterprise systems such as Veeva (eQMS) and Pfizer repositories.

Skills

Validation principles

Regulatory requirements

Project management

Independent decision making

Communication

Computerized systems

Education

Bachelor's degree

Master's degree

PhD

Associate's degree

High school diploma

Tools

Veeva (eQMS)

Pfizer Document Repositories

Pfizer Equipment Maintenance System

Job description

Pfizer in Andover, MA is seeking a Quality Assurance professional to oversee the validation program, review validation documents, and support change controls. The role requires blending regulatory knowledge with hands-on validation activities and strong communication with project teams.

Ideal candidates have a solid grasp of GMP guidance and experience in a matrixed environment, with proficiency in enterprise systems like Veeva and Pfizer repositories.