Documentation Specialist

Australia-Employment; Indianapolis (IN); On-site; USD 30,000 - 34,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

PTO/vacation policy

Paid holidays

Bonus programs

Tuition reimbursement/training

Job summary

Jobot seeks a Documentation Specialist in Indianapolis to support quality‑related processes, ensuring regulatory compliance and proper document control. You will manage both physical and digital records, oversee access, and coordinate cross‑functional workflows to sustain accurate, audit‑ready documentation.

The role emphasizes GDP/GMP familiarity, CFR 820.40 alignment, and ISO 13485 references, with opportunities for training and growth within a medical device environment.

Qualifications

• GDP/GMP familiarity and regulatory expectations for controlled documents and records.
• Experience with CFR 820.40 (Document Control) and ISO 13485 document management requirements is preferred.

Responsibilities

• Ensure all documents meet regulatory requirements, quality standards, and internal procedures before release.
• Scan, organize, and maintain both physical and digital files, including archiving historical records for long‑term retention.
• Manage user access, permissions, and system integrity within internal document control or ERP systems.
• Schedule recurring and ad‑hoc meetings to support workflow needs.
• Review documents for formatting accuracy, compliance, and proper version control.
• Collaborate with cross‑functional teams to support document workflows and resolve discrepancies.
• Maintain record retention timelines and ensure accessibility for audits.
• Process approved changes promptly in ERP or document control systems.
• Maintain repositories by uploading current versions and removing outdated revisions.

Skills

Bilingual English/Spanish

Regulatory knowledge

Document control understanding

Cross-functional collaboration

Tools

Excel

Word

PowerPoint

Access

Outlook

Job description

Documentation Specialist

$22 - $25 per hour | Indianapolis, IN | On-site | Consulting

Join a Top leading company in the Medical Device industry!

A bit about us:

Join a Top leading company in the Medical Device industry!

Why join us?

• Medical, dental, and vision insurance
• 401(k) and company match
• PTO/vacation policy
• Paid holidays
• Bonus programs
• Tuition reimbursement/training

Job Details

The Quality Support Coordinator Provides administrative and operational support for quality‑related processes, including performance tracking, reporting, and coordination of internal and external feedback.

Hours: 1st shift 8am-430pm

Days: Monday-Friday

Job Requirements

• Ensure all documents meet regulatory requirements, quality standards, and internal procedures before release.
• Scan, organize, and maintain both physical and digital files, including archiving historical records for long‑term retention.
• Manage user access, permissions, and system integrity within internal document control or ERP systems.
• Schedule recurring and ad‑hoc meetings as requested by internal departments to support workflow needs.
• Review documents for formatting accuracy, compliance, and proper version control.
• Collaborate with cross‑functional teams to support document workflows, resolve discrepancies, and maintain consistency across documentation practices.
• Maintain record retention timelines and ensure documentation is accessible for internal and external audits.
• Process approved changes promptly, including updating information within internal ERP or document control systems.
• Maintain internal viewing or document repositories by uploading current versions and removing outdated revisions.

Qualifications

• Computer skills: Excel, Word, PowerPoint, Access, Outlook
• Familiarity with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP), as well as general regulatory expectations for controlled documents and records.
• Understanding of document control principles aligned with standards such as CFR 820.40 (Document Control) and ISO 13485 sections related to document and record management (e.g., 4.2.3, 4.2.4, 4.2.5) is preferred.
• Bilingual (English/Spanish) a plus

Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.

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