Documentation Control Specialist (Pharma) - Intellectt INC

Role: Documentation Control Specialist (Pharma)

Location: New Brunswick, NJ

Duration: 24 Months on W2

Key Responsibilities:

• Manage validation documentation in automated systems, including control and archiving.
• Perform quality reviews of IQ/OQ/PQ protocols, test scripts, and validation reports.
• Collaborate with CQV and engineering teams to align documentation with project milestones.
• Assist in audits and inspections by providing necessary documentation.
• Ensure compliance with FDA, cGMP, and internal quality standards in all document control activities.

Qualifications:

• Education: Bachelor's degree in Life Sciences, Engineering, or a related field.
• Experience: 8+ years in document control and quality assurance within pharmaceutical settings.
• Skills:
  • Expertise in validation documentation management and quality review processes.
  • Strong understanding of regulatory requirements (FDA and cGMP).
  • Excellent attention to detail and organizational skills.
  • Proficiency in TOP review and compilation processes.