Job Description

Title: Sr. Quality Assurance Documentation Specialist

Status: 6-month contract

Location: 1 day a week onsite in Boston, MA

Hours: Part-time 15-20 hours per week

Compensation: $50 an hour

Overview

We are seeking a part-time Senior QA Document Specialist contractor to join the team. This candidate will be responsible for the oversight, management, and maintenance of Quality Docs, Training, and Quality Management System (QMS).

Day to Day responsibilities:

• Create, revise, and maintain regulated process documents (e.g., Standard Operating Procedures, etc.) in accordance with established guidelines and timelines.
• Route documents for review and approval, ensuring compliance with documented procedures and quality standards.
• Provide guidance and support to internal customers in creation and maintenance of functional area procedures and data management.
• Collaborate with functional areas to ensure documents are reviewed and approved.
• Update document status and metadata in Veeva based on feedback from document owners and stakeholders.

Required Skills:

• Bachelor’s degree in life science, computer science or health-related field. Advanced degree preferred.
• 5+ years' experience managing Veeva Quality Management Systems & administering Computerized Systems within a regulated environment (GCP, GLP, GMP).
• Experience with Veeva system configuration and Computer System Validation (CSV)
• Knowledge of GxP regulations and approaches to System Life Cycles (SLC) and GAMP

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