Document Turnover Specialist

ALLIANCE BIOTECH SOLUTIONS LLC • Raleigh, NC

8d • Onsite

About The Position

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

• 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.

Responsibilities

• Review manufacturing, laboratory, validation, and equipment documentation for completeness, accuracy, and compliance with GDP and cGMP requirements.
• Coordinate the turnover of GMP documentation packages to Quality Assurance, ensuring all required records are complete and properly organized.
• Identify documentation deficiencies, missing signatures, or data discrepancies and work with cross-functional teams to resolve issues promptly.
• Maintain documentation status trackers and manage records within Electronic Document Management Systems (EDMS) and other quality systems.
• Partner with Manufacturing, QA, QC, Validation, Engineering, and Document Control to facilitate efficient document flow and timely package completion.
• Support facility commissioning, qualification, validation, batch release, and audit readiness by ensuring documentation is complete, accurate, and inspection-ready.
• Participate in continuous improvement initiatives to enhance documentation quality, compliance, and process efficiency.

Benefits

• Industry competitive wage as a full-time employee
• 20 days flexible Paid Time Off
• Medical, Dental and Vision Insurance with low employee cost
• Employer paid long term and short-term disability
• 401k plan with employer contributions

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level