Quality Assurance Engineer

3 days ago


Boston, Massachusetts, United States Vastek, Inc. Full time
About the Role

We are looking for a Quality Assurance Engineer to support the Validation program at Vastek, Inc.

Company Overview

Vastek, Inc. specializes in Engineering, Validation, Regulatory, IT, and NON-IT areas primarily focused on Pharmaceutical/Life Sciences and Medical device companies.

Key Responsibilities

This position involves developing validation plans, qualification protocols, and reviewing validation documentation to ensure systems are qualified according to regulatory agencies, clients, and specifications.

  • Experience with equipment and/or computer system validation is highly valued.
  • Able to assess deviations that affect validation with minimal assistance.
  • Able to work on moderate Corrective Action Preventive Action (CAPA) resulting from deviations, internal audits, protocol discrepancies, global quality audits, or regulatory inspections.
  • Experience with autoclaves and VHP systems is an asset.
  • Able to speak as a Validation SME in audits.

Requirements:

  • 2+ years of experience in validation.
  • Bachelor's degree required.
  • Computer system validation (CSV) experience.
  • GMP compliance expertise.
  • Previous experience with mechanical validation, CSV, change control, CAPAs/deviations, data integrity, and project management.

Salary Estimate: $80,000 - $100,000 per year



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