Document Control Specialist I

Cube Hub Inc.; Round Lake (IL); Presencial; USD 34.000 - 55.000; Jornada completa

Descripción de la vacante

Cube Hub Inc. in Round Lake, IL is seeking a Document Control Specialist I for a 3-month contract to ensure GMP/GLP documentation accuracy and compliance. The role supports document management systems, audits, labeling processes, and product configuration activities onsite.

Responsibilities include reviewing and approving documentation, assisting with UAT and training materials, and coordinating document changes while maintaining thorough records for timely product releases.

Formación

• Knowledge of product and document configuration management.
• Intermediate proficiency with document management software and Microsoft Word.
• Understanding of FDA regulations, GMP, and GLP requirements.
• Knowledge of product configuration, design methodologies, and complex manufacturing processes.
• Strong project management, analytical, conceptual, and problem-solving skills.
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational skills.
• Ability to manage multiple projects simultaneously and meet strict deadlines.
• Ability to adapt to changing priorities and work independently with minimal supervision.
• Strong interpersonal skills and the ability to work effectively in a team environment.
• Working knowledge of related business systems.

Responsabilidades

• Review, approve, and maintain GMP/GLP manufacturing documentation and related records.
• Conduct internal audits of SOPs, training records, and other documentation as needed.
• Support engineering teams in preparing product documentation, product configuration records, and document change request packages.
• Manage document configuration and product data management activities.
• Assist with user acceptance testing (UAT) and the development of training materials.
• Train internal and external personnel on documentation and labeling processes and systems.
• Maintain, proofread, revise, and manage internal documents and SOPs.
• Review documentation for accuracy and compliance, ensuring all required elements are complete and properly assembled for review and approval.
• Route, release, or reject documents as appropriate.
• Participate in project teams and support documentation system implementation and improvement activities.

Conocimientos

Document configuration management

Microsoft Word

FDA GMP GLP awareness

Project management

Attention to detail

Communication skills

Team collaboration

Educación

Bachelor's degree (B.A. or B.S.)

Herramientas

Document management software

Descripción del empleo

Contract Duration: 3 Months

Position Summary

The Document Control Specialist I reviews and approves GMP/GLP manufacturing and related documentation to support timely product and system release. This role ensures documentation accuracy, compliance with established procedures, and adherence to FDA regulations and Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). The specialist also supports document management systems, internal audits, training materials, labeling processes, and product configuration activities.

Key Responsibilities

• Review, approve, and maintain GMP/GLP manufacturing documentation and related records.
• Conduct internal audits of Standard Operating Procedures (SOPs), training records, and other documentation as needed.
• Support engineering teams in preparing product documentation, product configuration records, and document change request packages.
• Manage document configuration and product data management activities.
• Assist with user acceptance testing (UAT) and the development of training materials.
• Train internal and external personnel on documentation and labeling processes and systems.
• Maintain, proofread, revise, and manage internal documents and SOPs.
• Review documentation for accuracy and compliance, ensuring all required elements are complete and properly assembled for review and approval.
• Route, release, or reject documents as appropriate.
• Participate in project teams and support documentation system implementation and improvement activities.

Required Skills and Qualifications

• Knowledge of product and document configuration management.
• Intermediate proficiency with document management software and Microsoft Word.
• Understanding of FDA regulations, GMP, and GLP requirements.
• Knowledge of product configuration, design methodologies, and complex manufacturing processes.
• Strong project management, analytical, conceptual, and problem-solving skills.
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational skills.
• Ability to manage multiple projects simultaneously and meet strict deadlines.
• Ability to adapt to changing priorities and work independently with minimal supervision.
• Strong interpersonal skills and the ability to work effectively in a team environment.
• Working knowledge of related business systems.

Education and Experience

• Bachelor's degree (B.A. or B.S.) required.
• 3–5 years of relevant experience in document control, documentation management, manufacturing, or a related field.
• Ability to communicate technical and project management issues effectively, both verbally and in writing.

Additional Requirements

• Must be able to work onsite.
• Must be available to work the Wednesday–Sunday, 8:00 AM–5:00 PM schedule.