Documentation Control Lead

New Brunswick, United States | Posted on 10/02/2024

• Industry Pharma/Biotech/Clinical Research
• Job Type Contract
• Work Experience 4-5 years
• State/Province New Jersey
• Country United States

The Document Control/QA Specialist will be responsible for maintaining the lifecycle of validation documents within an automated system. This role involves performing quality reviews of validation protocols, ensuring compliance with internal and regulatory standards.

Key Responsibilities:

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

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• 8+ years of experience in document control and quality assurance in pharmaceutical settings.
• Expertise in validation documentation management and quality review processes.
• Strong understanding of regulatory requirements, including FDA and cGMP.
• Excellent attention to detail and organizational skills.