Senior Document Control Specialist

OCUGEN OPCO INC • East Whiteland Township, PA

3d • Onsite

About The Position

The Senior Document Control Specialist is responsible for managing GxP-controlled documentation supporting Manufacturing and Quality Control (QC) operations using the Veeva Quality Suite. This role ensures documents are accurate, current, compliant, and inspection-ready, supporting Ocugen’s evolving manufacturing and regulatory needs.
This is a hands-on role requiring strong document control expertise, experience in regulated environments, and the ability to partner effectively with cross-functional teams

Requirements

• Bachelor’s degree in a scientific, technical, or related field
• Strong hands-on experience with Veeva Quality Docs
• Solid understanding of GxP documentation requirements and document control best practices
• Experience supporting Manufacturing and/or QC documentation in a regulated environment
• Ability to manage document lifecycle activities independently and with attention to detail

Nice To Haves

• Experience supporting regulatory inspections (e.g., FDA)
• Familiarity with Veeva Training or Veeva eQMS
• Experience in biotech or pharmaceutical manufacturing environment

Responsibilities

• Execute the end-to-end lifecycle of controlled GxP documents in Veeva Quality Docs, including SOPs, work instructions, forms, protocols, and records.
• Serve as a Veeva Quality Docs (VQD) subject matter expert, providing guidance on system usage, hands-on system support and supporting approved configuration changes in alignment with validation and GxP requirements.
• Ensure documents are initiated, reviewed, approved, issued, maintained, and archived in accordance with internal quality systems and regulatory requirements
• Serve as a hands-on partner to Manufacturing and QC teams by maintaining accurate, current, and accessible documentation that supports daily operations
• Provide backup support for Quality business capability owners, including Training, QMS administration, and system administration.
• Coordinate document updates driven by change controls, deviations, CAPAs, audits, and regulatory requirements.
• Maintain inspection and audit readiness, including document completeness, version control, traceability, and data integrity
• Collaborate with QA, QC, Manufacturing, and Regulatory to support compliant execution and continuous improvement
• Track and report basic document metrics to provide visibility into document status, throughput, and risks
• Support migration, scanning, indexing, and maintenance of electronic records within Veeva as needed
• Contribute to the evolution of document control practices and standards as Ocugen’s manufacturing and quality systems scale

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees