Document Control Specialist — Quality Systems & Compliance

Reporting to: Quality Systems Manager, Hubot CDMO, South Bend, Indiana, USA This position is not eligible for visa sponsorship. 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. Why Hubot🚀 Growth-Stage Opportunity Join a scaling CDMO at a pivotal moment with 25–30% projected YoY growth through 2030, you'll have real influence over how systems and programs develop.🔬 Dual-Function Depth This role sits at the intersection of stability science and formulation development giving you breadth across OTC, cosmetic, and medical device product categories.🏭 Regulated Industry Experience Our operations run under FDA 21 CFR 210/211, ICH stability guidelines, ISO 13485, ISO 9001, ISO 14001, GMP, Health Canada and ISO 22716 cGMP standards sharpening expertise that travels across the industry.🤝 Cross-Functional Visibility You'll work directly with R&D, QC, and production leadership with clear visibility and direct impact on product quality and client deliverables. Role OverviewFor 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. 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 specificationsIssue and track document control numbers; manage revision history, approval routing, and archivalEnsure all controlled documents comply with change control procedures and maintain full traceabilityMaintain version integrity and GDP-compliant audit trails across Quality and ProductionReview documentation for completeness, accuracy, and proper authorization before releaseServe as the QMS knowledge hub - communicate updates, version changes, and document statuses across departmentsReview Batch Records, Packing Records, and production logs for GDP compliance and customer-specific requirementsCoordinate with U.S.-based QA for batch disposition support and raw material documentationPhase 2 Automation & Continuous Improvement (Month 9+)Identify and eliminate repetitive manual document control tasks through digital workflows and automation toolsPartner with IT and Quality Systems to implement electronic change control, e-signatures, and version managementPropose and develop QMS templates, communication plans, and scalable documentation frameworksSupport integration of document management systems (DMS) with ERP platforms (e.g., SAP, Veeva, MasterControl)What You Bring3-5 years of experience in a GMP-regulated environment - pharmaceutical, personal care, or chemical manufacturingStrong working knowledge of FDA 21 CFR 210/211, ISO 13485, ISO 22716Hands-on experience with Document Management Systems (DMS), ERP platforms (SAP preferred), and Microsoft Office SuiteDemonstrated understanding of Good Documentation Practices (GDP) and audit-readinessExceptional attention to detail, structured thinking, and follow-throughStrong written English communication skills for cross-functional collaboration with U.S. teamsExposure to or interest in QMS digitization, automation, or process improvement methodologiesBA/BS in Life Sciences, Pharmacy, Biotechnology, Business, or a related field How We Measure SuccessControlled 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 monthsQMS automation proposal submitted By Month 9 What We OfferCompetitive base salary commensurate with experienceMedical, dental, and vision insurance401(k) with company contributionPaid time off and holidays Apply TodayCome build programs that protect products and the people who use them.🌐 www.hubot.us Hubot, Inc. is an Equal Employment Opportunity / Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.