GMP/GLP Document Control Specialist I

Planet Pharma; Round Lake (IL); On-site; USD 28,000 - 36,000; Full time

Job summary

Planet Pharma is seeking a Documentation Specialist to review, approve, and manage GMP/GLP documentation supporting timely product releases. You will audit SOPs, training records, and engage in training on documentation processes.

This role requires strong attention to detail, knowledge of FDA regulations, and the ability to lead multiple documentation projects with minimal supervision. On-site work in Illinois is expected.

Qualifications

• Proficient in product/document configuration management.
• Intermediate level in document management software (e.g., Word).
• Strong project management skills.
• Excellent conceptual, analytical, written and verbal communication.
• Understanding of design methodology and manufacturing processes.
• Ability to work under deadlines and changing priorities with minimal supervision.
• Strong attention to detail and teamwork.
• Knowledge of FDA Regulations, GLP, GMP.

Responsibilities

• Document configuration and product data management.
• Assist in the execution of user acceptance testing.
• Create and write training materials.
• Assist in training internal and external personnel on documentation and labeling processes and systems.
• Maintain and own internal documents.
• Review documentation for accuracy and compliance to procedures.
• Route, release or reject as appropriate.
• Maintain, proof read, and change as needed Standard Operating Procedures.

Skills

Document management

Word processing

Project management

Communication skills

FDA Regulations knowledge

Team collaboration

Education

BA/BS + 3-5 years experience

Tools

Document control systems

Job description

Planet Pharma is seeking a Documentation Specialist to review, approve, and manage GMP/GLP documentation supporting timely product releases. You will audit SOPs, training records, and engage in training on documentation processes.

This role requires strong attention to detail, knowledge of FDA regulations, and the ability to lead multiple documentation projects with minimal supervision. On-site work in Illinois is expected.