Document Control Specialist

Net2Source (N2S); Indianapolis (IN); On-site; USD 48,000 - 56,000; Full time

Job summary

Net2Source (N2S) is seeking an experienced Document Controller to support the GQC QA Operations team, managing the end-to-end document control lifecycle for quality documents aligned with GQS, LQS, and regulatory expectations.

The role ensures documents are inspection-ready, reviewed for accuracy, and archived in controlled repositories. Strong 4+ years in GxP document control and hands-on Veeva QualityDocs experience are required, with collaboration across QA and site functions.

Qualifications

• Minimum of 4 years of document control experience in a regulated (GxP) environment.
• Hands-on experience with Veeva QualityDocs is required.
• Experience supporting inspections, audits, periodic reviews, and gap assessments.

Responsibilities

• Owns and manages the end-to-end document control lifecycle for QA documentation in compliance with GQS and LQS.
• Provides SME guidance on document control standards to QA and cross-functional partners.
• Reviews QA documentation for accuracy, formatting, and regulatory compliance.
• Leads periodic review and gap assessment activities, identifying gaps, risks, and remediation needs.
• Coordinates document routing through review and approval workflows to ensure timely execution.
• Maintains controlled document repositories for current, traceable documents accessible for ops and inspections.
• Tracks and reports documentation status and metrics to QA Operations leadership.
• Supports inspection readiness by ensuring documents are ready and site-aligned.
• Partners with QA and site stakeholders to support documentation strategies for new processes and changes.
• Identifies opportunities to improve document control efficiency and compliance.

Skills

Document control

GxP compliance

Cross-functional collaboration

Tools

Veeva QualityDocs

Job description

Duration: 18+ Months Contract (extendable)

Pay Range: $35 - $41 per hour on W2.

Qualifications:

The experienced Document Controller supports the GQC QA Operations team by managing the full lifecycle, control, and governance of quality documentation required for compliance with Global Quality Standards (GQS), Client's Quality Standards (LQS), and applicable departmental procedures. This role ensures documentation is consistently controlled, inspection-ready, and aligned with regulatory expectations, while providing subject matter expertise and guidance on document control processes across QA and site functions.

Minimum Experience Requirements:

• Minimum of 4 years of experience in document control within a regulated (GxP) pharmaceutical or biotechnology environment
• Demonstrated hands-on experience managing controlled documents using Veeva QualityDocs (required)
• Experience supporting inspections, audits, periodic reviews, and documentation gap assessments

Educational Requirements:

• Strong written and verbal communication skills
• Detailed knowledge of Quality policies, procedures, and document control principles
• Strong attention to detail, organizational skills, and ability to manage multiple priorities
• Proven ability to work independently and influence across functions

Responsibilities:

Key Responsibilities:

• Owns and manages the end-to-end document control lifecycle for QA documentation, including creation, revision, review, approval, issuance, archiving, and retirement, in compliance with GQS and LQS requirements
• Provides subject matter expertise on document control standards, processes, and best practices to QA and cross-functional partners
• Reviews QA documentation for accuracy, completeness, formatting, and compliance with quality standards and regulatory expectations
• Leads and supports periodic review and gap assessment activities, identifying documentation gaps, risks, and remediation needs
• Coordinates and facilitates document routing through electronic or manual review and approval workflows, ensuring timely execution
• Maintains controlled document repositories to ensure documents are current, traceable, and readily accessible for operations and inspections
• Tracks, monitors, and reports documentation status, metrics, and deliverables to QA Operations leadership
• Supports inspection readiness activities by ensuring controlled documents are inspection‑ready and aligned with site practices
• Partners with QA and operational stakeholders to support documentation strategies for new processes, changes, and remediation efforts
• Identifies opportunities to improve document control efficiency, consistency, and compliance