What are the responsibilities and job description for the Document Control Specialist - GMP/ Pharma position at Hubot | Tri Pac, Inc. CDMO?
Document Control Specialist - Quality Systems & Production (CDMO)
📍 South Bend, Indiana | Full-Time | On-Site | Reporting to Quality Systems Manager
Be the operational backbone connecting Quality Systems and Production at Hubot, Inc. (CDMO) a leading developer and manufacturer of aerosols, liquids, tubes, and suppositories for personal care and pharmaceutical brands.
This is a hybrid role (in responsibility) hands-on document control today, system innovation tomorrow. Your attention to detail will keep our quality system alive and compliant; your curiosity will help us modernize it.
Why Join Hubot?
🚀25–30% YoY growth with momentum through 2030
🌟4.8 Glassdoor | 4.7 Indeed | 95% recommend | Wellbeing 79
🧭Impact that counts: Your documents enable batch release and audit readiness in the U.S.
🌍Global collaboration: Daily partnership with U.S. QA/Manufacturing/Validation/Regulatory
📈Career path: : Pathway to Quality Engineer or Senior Quality Systems roles.
💡Opportunity to Innovate: Transform manual document control into a digital, automated system.
What you’ll do
- Manage and maintain controlled documents within the Quality Management System (QMS) SOPs, WIs, forms, CAPAs, and specifications.
- Review and approve production documentation - Batch and Packing Records, Raw Material Inspections - ensuring GDP and release readiness.
- Track, issue, and archive controlled documents, maintaining version integrity and traceability.
- Communicate QMS updates to Production and Quality teams to keep the organization aligned.
- Over time, automate and streamline document control processes for improved efficiency and audit readiness.
Who you are (Pharma-first)
- 5 years in a GMP-regulated manufacturing environment (pharma, personal care, or chemical).
- Fluent in FDA 21 CFR 210/211, ISO 9001, and ISO 22716.
- Proficient in Microsoft Office, Adobe Acrobat, and document control software (SAP or DMS).
- Sharp eye for accuracy; thrives on structure but motivated to improve it.
- Curious, collaborative, and ready to grow from documentation expert to systems innovator.
🎯Success metrics
- 100% document version control accuracy.
- 95% on-time approvals and change closures.
- GDP adherence ≥98% on production documentation.
- 20% reduction in document cycle time within 6 months.
- One automation or improvement initiative launched by Month 9.
If you take pride in precision and want to help modernize how quality documentation works we’d love to meet you.
Apply via LinkedIn or message for a confidential conversation.
See www.hubot.us for company overview.
#DocumentControl #QualitySystems #QMS #GMP #ISO9001 #ISO22716 #Manufacturing #ProcessImprovement #CDMO
