Documentation & Logistics Specialist (FDA Regulated Environment)

Job Title: Documentation & Logistics Specialist (FDA Regulated Environment)

Location: North Carolina, USA (100% Onsite)

Employment Type: Contract (via ProQuality Network)

Start Date: Immediate availability preferred

Citizenship: Open to U.S. Citizens and Permanent Residents (local candidates strongly preferred)

Position Summary

Our client, a global leader in the life sciences industry, is seeking an experienced Documentation & Logistics Specialist to support a start-up manufacturing facility in North Carolina. This is a 100% onsite contract opportunity offered through ProQuality Network, ideal for professionals who thrive in dynamic environments and have extensive experience in documentation systems, controlled records, and material logistics within FDA-regulated settings.

The ideal candidate must be detail-oriented, highly organized, and capable of managing documentation workflows and logistical operations to support commissioning, qualification, and start-up activities.

Key Responsibilities

Manage the control, review, issuance, and archival of GMP documentation in support of manufacturing and quality operations
Coordinate documentation workflows across departments including Quality Assurance, Engineering, Validation, and Supply Chain
Organize, track, and maintain records of batch documentation, standard operating procedures (SOPs), protocols, and reports
Support document lifecycle processes including revision control, approvals, and secure storage
Assist with inventory tracking, material movement, labeling, and coordination of supplies and equipment
Ensure compliance with cGMP, internal procedures, and regulatory expectations for document integrity and traceability
Facilitate timely receipt and distribution of controlled documents during commissioning and startup phases
Prepare documentation metrics and status reports for internal review and project tracking
Interact with cross-functional teams and support audits or inspections by maintaining documentation readiness
Perform other administrative and documentation-related tasks as assigned to support site operational goals

Required Qualifications

Bachelor s degree in a scientific or technical field (e.g., Life Sciences, Engineering, Chemistry, Biology, or related discipline)
Minimum of 5 years of hands-on experience in documentation control and/or logistics within a GMP/FDA-regulated manufacturing environment (pharmaceutical, biotech, or medical device industry)
Strong working knowledge of document control practices, good documentation practices (GDP), and electronic documentation systems
Experience supporting facility startup or expansion projects preferred
Ability to handle multiple priorities and work in a fast-paced, compliance-driven environment
Excellent organizational skills and strong attention to detail
Effective written and verbal communication skills

Preferred Qualifications

Familiarity with electronic documentation systems (e.g., Veeva, MasterControl, TrackWise)
Experience with ERP systems for logistics and material movement
Understanding of commissioning and qualification (C&Q) documentation
Prior experience working in a start-up or greenfield facility