What are the responsibilities and job description for the Document Control Specialist (GMP) position at Hubot | Tri Pac, Inc. CDMO?
Reporting to: Quality Systems Manager, Hubot CDMO, South Bend, Indiana, USA
Job Location : South Bend,Indiana
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.
What you'll do ?
- 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 QualityDocs, MasterControl 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.
What you bring
- 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, MasterControl, TrackWise, ComplianceWire or similar).
- Strong attention to detail, organization and follow-through.
- Clear written and verbal communication skills.
- Proficiency in Microsoft Word, Excel and Adobe Acrobat.
Nice to have
- 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.
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
What We Offer
- Competitive base salary commensurate with experience
- Medical, dental, and vision insurance
- 401(k) with company contribution
- Paid time off and holidays
Apply Today
Come 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.