Project Engineer / Document Turnover Specialist

Job overview

The Project Engineer / Document Turnover Specialist role is onsite in Raleigh, NC; compensation is not specified. Alliance Biotech Solutions provides biopharmaceutical engineering and validation services, including commissioning, qualification, and validation support. The specialist coordinates and reviews GMP documentation so manufacturing, laboratory, validation, and quality records are complete and ready for Quality Assurance review. By identifying deficiencies and coordinating timely resolution across teams, the role supports batch release, commissioning, validation, audit readiness, and operational compliance.

What you'll do

• Review manufacturing, laboratory, validation, and equipment documentation for completeness, accuracy, and GDP and cGMP compliance
• coordinate GMP documentation packages for Quality Assurance
• identify missing signatures, deficiencies, and data discrepancies and work with teams to resolve them
• maintain status trackers and records in EDMS and quality systems
• partner with Manufacturing, QA, QC, Validation, Engineering, and Document Control
• support commissioning, qualification, validation, batch release, and audit readiness
• participate in continuous improvement initiatives.

What we're looking for

Skills & competencies

project engineer

document turnover specialist

raleigh nc

onsite

full-time

alliance biotech solutions

gmp documentation

cgmp

good documentation practices

quality assurance

edms

validation

audit readiness

Work arrangement

• Weekend coverage required

Benefits & perks

• 20 days flexible paid time off
• medical, dental, and vision insurance
• employer-paid short- and long-term disability
• 401(k) employer contributions.

Why this role

Equivalent GMP industry experience may be considered in place of a bachelor’s degree. Benefits include 20 days of flexible paid time off, medical, dental, and vision insurance, disability coverage, and 401(k) employer contributions.

About the employer

Alliance Biotech Solutions LLC is hiring for this role. Industry: Engineering Services. Sector: 54.