Document Control Specialist

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

1st Shift - 8AM to 5PM - Wednesday to Sunday

This section focuses on the main purpose of the job in one to four sentences. 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.

This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.

The incumbent will perform other duties assigned.

• 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

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 Include the education and experience that is necessary to perform the job satisfactorily.
• 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.

Notes:

1st Shift - 8AM to 5PM - Wednesday to Sunday

VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status