Senior QA Validation Specialist – Validation & Compliance

Pfizer; United States; On-site; USD 83,000 - 138,000; Full time

Benefits offered by this job

Referral bonus

Relocation assistance (possible)

Job summary

Pfizer is seeking a Quality Assurance/Validation professional to oversee the validation program at the Andover, MA site. You will review validation docs, approve change controls, and support project teams on compliance issues to maintain the validated state.

Expect active participation in continuous improvement and readiness for inspections. The role requires strong knowledge of GMP, 21 CFR Parts 11/210/211, and experience with validation practices.

Qualifications

• Bachelor's degree with 4+ years of experience or higher education equivalents.
• Strong understanding of validation principles and regulatory guidelines.
• Experience with validation/regulatory compliance documentation.
• Proficiency in project management and resource planning.
• Independent decision-making with strong communication skills.
• Experience with computerized systems and software applications.

Responsibilities

• Oversee validation documentation review and approvals.
• Review/approve change controls and assess validation impact.
• Support project teams on compliance and technical validation issues.
• Review investigations, commitments, and procedures related to validation.
• Resolve quality validation issues and contribute to continuous improvement.
• Maintain inspection readiness and utilize enterprise systems.

Skills

Validation principles

Regulatory standards

Project management

Independent decision-making

Communication skills

Computerized systems

Education

Bachelor's degree + 4+ yrs

Master's degree + 2+ yrs

PhD + 0+ yrs

Associate's degree + 8 yrs

High school diploma + 10 yrs

Tools

Veeva (eQMS)

Pfizer Document Repositories

Pfizer Equipment Maintenance System

Job description

Pfizer is seeking a Quality Assurance/Validation professional to oversee the validation program at the Andover, MA site. You will review validation docs, approve change controls, and support project teams on compliance issues to maintain the validated state.

Expect active participation in continuous improvement and readiness for inspections. The role requires strong knowledge of GMP, 21 CFR Parts 11/210/211, and experience with validation practices.