Document Turnover Specialist

Description

The Document Turnover (DTO) Specialist is responsible for coordinating, reviewing, and managing the turnover of GMP documentation to ensure manufacturing, laboratory, validation, and quality records are complete, accurate, and ready for Quality Assurance review and final approval. This role serves as a critical liaison between Manufacturing, Quality, Validation, Engineering, and Laboratory Operations, helping ensure documentation complies with Good Documentation Practices (GDP), cGMP requirements, and internal quality standards. The Document Turnover Specialist plays a key role in supporting batch release, facility commissioning, validation activities, audit readiness, and overall operational compliance by identifying and resolving documentation deficiencies before they impact production or project timelines.

Requirements

• Review manufacturing, laboratory, validation, and equipment documentation for completeness, accuracy, and compliance with GDP and cGMP requirements.
• Career summary: Bachelor's degree in Life Sciences, Engineering, Quality, or a related technical field; equivalent GMP industry experience will also be considered. 1–3 years of experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or related life sciences environment. Working knowledge of cGMP regulations, Good Documentation Practices (GDP), and data integrity principles (ALCOA+). Experience reviewing controlled GMP documentation such as batch records, validation documentation, laboratory records, or quality system records. Familiarity with Electronic Document Management Systems (EDMS), Quality Management Systems (QMS), or similar regulated documentation platforms. Strong organizational, communication, and problem-solving skills with exceptional attention to detail and the ability to manage multiple priorities. Self-motivated with the ability to work independently, collaborate across functional teams, and consistently meet deadlines in a fast-paced GMP environment.

About the Role

This role serves as a critical liaison between Manufacturing, Quality, Validation, Engineering, and Laboratory Operations, helping ensure documentation complies with Good Documentation Practices (GDP), cGMP requirements, and internal quality standards. The Document Turnover Specialist plays a key role in supporting batch release, facility commissioning, validation activities, audit readiness, and overall operational compliance by identifying and resolving documentation deficiencies before they impact production or project timelines.