Documentation and Logistics Specialist (FDA Regulated Industry)

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

Documentation and Logistics Specialist (FDA Regulated Industry)

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

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 possess 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 startup (CQ&S) 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 equipment inspection, unpacking, and repacking in accordance with internal procedures and regulatory standards.
• Execute activities related to equipment deliveries, transport, tracking, and on-site staging, ensuring accuracy and traceability throughout each phase.
• Manage qualification-related documents, ensuring complete traceability and compliance with FDA requirements, including accurate entries into the Kneat system.
• 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.

This is a contract role with ProQuality Network.