Document Control Specialist — Quality Systems & Compliance

Website: hubot.us
Job details:

📍 India (Remote) | Full-Time | Supporting U.S. Operations | IST–EST Overlap Required

Reporting to: Quality Systems Manager, Hubot CDMO, South Bend, Indiana, USA

Be the compliance backbone of a U.S. FDA-regulated CDMO from India.

Hubot, Inc. is a U.S.-based contract development and manufacturing organization (CDMO) specializing in aerosols, liquids, tubes, and suppositories for global pharmaceutical and personal care brands. As part of a deliberate expansion of our India operations through Hubot India Private Limited, we're building a high-caliber back-office Quality function that operates in lockstep with our U.S. team.

We're looking for a Document Control Specialist who will own the documentation lifecycle underpinning our Quality Management System (QMS) and Production remotely, rigorously, and with a long-term eye toward automation and digitization.

This is a high-visibility role within Hubot India with a direct line to U.S. regulatory, quality, and production leadership.

Why Hubot India ?

🚀 Growth-Stage Opportunity 25 - 30% YoY revenue growth forecast through 2030

🌐 Global Exposure Direct collaboration with U.S. Quality, Regulatory, and Operations teams

🔬 Regulated Industry Depth FDA 21 CFR 210/211, ISO 9001, ISO 22716 cGMP environments

📈 Defined Career Path Progression into Quality Systems Engineer or Senior Quality Specialist (India)

🤖 Phase 2 Innovation After stabilization, lead QMS automation and digital workflow transformation

Role Overview

For the first 6 - 9 months, this is a detail-intensive, documentation-heavy role focused on stabilizing and mastering Hubot's controlled document environment. You will learn the system deeply before you improve it. After that, your mandate expands into process optimization, automation design, and QMS modernization.

This role requires a 4–5-hour daily overlap with U.S. Eastern Time (EST/EDT).

Key Responsibilities

Phase 1 Document Control & QMS Administration (Months 1–9)

• Administer and maintain the QMS - SOPs, Work Instructions, forms, CAPAs, deviations, change controls, and specifications
• Issue and track document control numbers; manage revision history, approval routing, and archival
• Ensure all controlled documents comply with change control procedures and maintain full traceability
• Maintain version integrity and GDP-compliant audit trails across Quality and Production
• Review documentation for completeness, accuracy, and proper authorization before release
• Serve as the QMS knowledge hub - communicate updates, version changes, and document statuses across departments
• Review Batch Records, Packing Records, and production logs for GDP compliance and customer-specific requirements
• Coordinate with U.S.-based QA for batch disposition support and raw material documentation

Phase 2 Automation & Continuous Improvement (Month 9+)

• Identify and eliminate repetitive manual document control tasks through digital workflows and automation tools
• Partner with IT and Quality Systems to implement electronic change control, e-signatures, and version management
• Propose and develop QMS templates, communication plans, and scalable documentation frameworks
• Support integration of document management systems (DMS) with ERP platforms (e.g., SAP, Veeva, MasterControl)

What You Bring

• 5+ years of experience in a GMP-regulated environment - pharmaceutical, personal care, or chemical manufacturing
• Strong working knowledge of FDA 21 CFR 210/211, ISO 13485, ISO 22716
• Hands-on experience with Document Management Systems (DMS), ERP platforms (SAP preferred), and Microsoft Office Suite
• Demonstrated understanding of Good Documentation Practices (GDP) and audit-readiness
• Exceptional attention to detail, structured thinking, and follow-through
• Strong written English communication skills for cross-functional collaboration with U.S. teams
• Exposure to or interest in QMS digitization, automation, or process improvement methodologies
• BA/BS in Life Sciences, Pharmacy, Biotechnology, Business, or a related field

How We Measure Success

• Controlled document accuracy & version integrity 100%
• GDP adherence on production record reviews ≥ 98%
• On-time document routing & approval completion ≥ 95%
• Document cycle-time reduction 20% within 6 months
• QMS automation proposal submitted By Month 9

About Hubot India Private Limited

Hubot India is a wholly owned subsidiary of Hubot, Inc. (South Bend, Indiana, USA) established to build a world-class back-office and technical support function for our U.S. CDMO operations. We serve Fortune 500 clients and historical brands globally.

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Learn more: www.hubot.us

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