Document Control Specialist (GMP)

Hubot | Tri Pac, Inc. CDMO; South Bend (IN); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company contribution

Paid time off and holidays

Job summary

Hubot, Inc. in South Bend, Indiana is seeking a Document Control Specialist to manage the full lifecycle of GMP documentation. You will administer eDMS systems like Veeva and MasterControl, ensure cGMP compliance, and support audits and inspections.

The role requires 2–5 years of relevant experience, strong attention to detail, and excellent written/verbal communication. On-site in South Bend with competitive benefits and growth opportunities.

Qualifications

• Bachelor's degree in Life Sciences or related field, or associate degree with equivalent experience.
• 2–5 years of document control or QA documentation experience in pharma/CDMO/GMP environment.
• Working knowledge of cGMP, 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.

Responsibilities

• 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.

Skills

Attention to detail

Communication skills

Organizational skills

Microsoft Word

Education

Bachelor's degree in Life Sciences or Chemistry

Associate degree with equivalent experience

Tools

Veeva Vault QualityDocs

MasterControl

TrackWise

ComplianceWire

Job description

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.

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%
• Document cycle-time reduction 20% within 6 months

What We Offer

• 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.