Onsite Documentation & Logistics Specialist - FDA Start-Up

ProQuality Network; Northern (KY); Hybrid; USD 55,000 - 83,000; Part time

Job summary

ProQuality Network is seeking a Documentation & Logistics Specialist to support a startup manufacturing facility in a highly regulated environment. Onsite contract role focusing on document control, material logistics, and CQ&S activities.

The candidate will manage controlled documents, coordinate cross‑functional workflows, and ensure GMP compliance, while supporting audits and commissioning efforts in FDA-regulated settings.

Qualifications

• Bachelor's degree in a scientific or technical field.
• Minimum of 5 years' experience in documentation control and/or logistics in GMP/FDA environments.
• Strong knowledge of GDP and electronic documentation systems.
• Experience supporting startup or expansion projects preferred.
• Ability to manage multiple priorities in a compliance-driven setting.
• Excellent organizational and communication skills.

Responsibilities

• Manage GMP documentation control and archival for manufacturing and quality operations.
• Coordinate documentation workflows across QA, Eng, Validation, and Supply Chain.
• Track and maintain records for batch docs, SOPs, protocols, and reports.
• Support revision control, approvals, and secure storage of documents.
• Assist with inventory tracking, material movement, labeling, and supplies coordination.
• Ensure compliance with cGMP and regulatory expectations for traceability.
• Facilitate document distribution during commissioning and startup.
• Prepare metrics and status reports for project tracking.
• Interact with cross-functional teams and support audits/inspections.

Skills

Attention to detail

Organizational skills

Communication skills

Multi-tasking

GMP knowledge

Education

Bachelor's degree in Life Sciences/Engineering/Chemistry/Biology

Tools

Kneat system

Veeva

MasterControl

TrackWise

Job description

ProQuality Network is seeking a Documentation & Logistics Specialist to support a startup manufacturing facility in a highly regulated environment. Onsite contract role focusing on document control, material logistics, and CQ&S activities.

The candidate will manage controlled documents, coordinate cross‑functional workflows, and ensure GMP compliance, while supporting audits and commissioning efforts in FDA-regulated settings.