Document Control Specialist; GMP

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.

• Manage the full document lifecycle (creation, review, approval, issuance, revision, archival and retirement) for SOPs, work instructions, forms, specifications and master batch records.
• Administer the electronic document management system (eDMS), such as Veeva Vault Quality Docs, Master Control or similar.
• Process change controls for documents and route them for review and approval on time.
• Issue, reconcile and archive executed batch records, logbooks and controlled forms.
• Make sure documents meet 21 CFR Part 11, 21 CFR Parts 210/211, ICH Q7/Q10 and ALCOA+ data-integrity principles.
• Maintain document numbering, templates, version control and periodic review schedules.
• Support FDA inspections, client audits and internal audits by pulling records quickly and accurately.
• Coordinate document-related training assignments with the Learning Management System (LMS).
• Track and report document-control metrics, such as cycle time, overdue reviews and backlog.
• Partner with Manufacturing, QC, Validation, Regulatory and client teams to keep documentation right first time.

• Bachelor's degree in Life Sciences, Chemistry or a related field, or an associate degree plus equivalent experience.
• 2–5 years of document control or QA documentation experience in a pharmaceutical, biotech, CDMO or medical device GMP environment.
• Working knowledge of cGMP, Good Documentation Practices (GDP) and FDA regulations.
• Hands-on experience with an eDMS (Veeva, Master Control, Track Wise, Compliance Wire or similar).
• Strong attention to detail, organization and follow-through.
• Clear written and verbal communication skills.
• Proficiency in Microsoft Word, Excel and Adobe Acrobat.

• Experience with sterile or aseptic manufacturing, or commercial and clinical drug product.
• Exposure to eQMS migrations or document system implementations.
• ASQ Certified Quality Auditor (CQA) or Certified Pharmaceutical GMP Professional (CPGP) certification.

• Controlled document accuracy & version integrity 100%
• Document cycle-time reduction 20% within 6 months

• Competitive base salary commensurate with experience
• Medical, dental, and vision insurance
• 401(k) with company contribution
• Paid time off and holidays

Hubot, Inc. is an Equal Employment Opportunity / Affimative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.