GMP Documentation & Compliance Lead

VIVA USA Inc; Round Lake (IL); On-site; USD 60,000 - 95,000; Full time

Job summary

VIVA USA Inc is seeking a Documentation Specialist to review and approve GMP/GLP manufacturing documentation and support timely product releases. The role includes auditing SOPs, training records, and related documents, and guiding engineering in product documentation and change requests.

You will train staff on labeling and documentation processes, participate in project teams, maintain internal documents, and ensure accuracy and compliance across procedures, configurations, and systems.

Qualifications

• Experience with GMP/GLP documentation and record control.
• Ability to review and approve documentation for product releases.
• Familiarity with SOPs, training records and change control.

Responsibilities

• Document configuration and product data management
• Aid in user acceptance testing execution
• Aid in writing training materials
• Assist training internal and external personnel on documentation and labeling processes
• Maintain and own internal documents
• Review documentation for accuracy and compliance; route, release or reject as appropriate
• Maintain, proofread, and update SOPs

Skills

Documentation management

Word processing

Auditing & compliance

Project coordination

Training & coaching

Education

Bachelor's degree in a related field

Tools

MS Word

Document management systems

Job description

VIVA USA Inc is seeking a Documentation Specialist to review and approve GMP/GLP manufacturing documentation and support timely product releases. The role includes auditing SOPs, training records, and related documents, and guiding engineering in product documentation and change requests.

You will train staff on labeling and documentation processes, participate in project teams, maintain internal documents, and ensure accuracy and compliance across procedures, configurations, and systems.