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

Main Purpose

Review and approve GMP/GLP Manufacturing and related documentation to support timely product and system release.

Conduct internal audit of SOPs, training records, and other document types on an as needed basis.

Assist and guide engineering in the preparation of product documentation, product configuration and document change request package development.

Responsible for activities related to providing required documentation and implementing related documentation systems.

Assist in providing training on documentation and labeling processes and systems.

Participate on project teams as needed.

Responsibilities

• Document configuration and product data management
• Aid in the execution of user acceptance testing
• Aid in the creation/writing of training materials
• Assist in training internal and external personnel on documentation and labeling related processes and systems
• Maintain and own internal documents
• Review documentation for accuracy and compliance to procedures.
• Route, release or reject as appropriate.
• Ensure all document and system elements are identified, accurate and assembled for review and approval.
• Maintain, proof read, and change as needed Standard Operating Procedures

Knowledge, Skills, and/or Abilities

• Product/document configuration.
• Intermediate level and document management (e.g. Word) software skills
• Project Management Skills
• Must have excellent conceptual, analytical, written and verbal configuration skills
• Comprehension of design methodology, product configuration and complex manufacturing processes
• Ability to work under strict deadlines and changing priorities with minimal supervision
• Strong interpersonal skills and great attention to detail are necessary
• Must be a strong team player with good problem solving, and good verbal and written communications skills
• Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Applications of Good laboratory Practices, and Application of Good Manufacturing Practices

Education and Experience

• B.A. or B.S. and 3-5 years related experience (in-house or acquired outside).
• Ability to discuss normally encountered technical or project management issues, both verbally and in written form.
• Knowledge of product/document configuration management.
• Working knowledge of related business systems.

Pay range

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