Job Title: Document Control Associate

Job Description

The Document Control Associate will work closely with the document control and Quality Assurance (QA) teams. The role involves managing quality records, supporting record issuance, and tracking documentation corrections. The associate will also assist in closing out quality records, maintaining training records, and reviewing training documents within the lab and quality departments.

Responsibilities

• Manage quality records and upload them into the system.
• Support record issuance, logbooks/notebooks/lab notebooks issuance, retrieval, and archival.
• Track and follow up on documentation corrections and action items.
• Support the team in closing out quality records and provide quality final document review.
• Maintain and verify training records and batch records.
• Review training documents for the lab and quality departments in accordance with training and testing requirements.

Essential Skills

• Document control and management of document records - 2+ years
• Good Manufacturing Practice (GMP) - 2-4 years
• Good Documentation Practice (GDP)
• Experience in a GMP environment - 2-4 years
• Experience with GDP - 2-4 years

Additional Skills & Qualifications

• Bachelor's Degree in Sciences
• Experience in Pharmaceutical or Medical Device Environment

Work Environment

The position operates within a regulated environment requiring adherence to GMP and GDP standards. The work involves interaction with both document control and QA teams, managing and verifying various records, and working closely with lab and quality departments. The work setting is professional, with a focus on accuracy and compliance.