Document Control Specialist

Spectraforce Technologies, Inc.; Round Lake (IL); On-site; USD 55,000 - 65,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Document Control Specialist in Round Lake, IL for a 3-month assignment. The role supports GMP/GLP documentation, change control, and timely product releases.

Responsibilities include auditing SOPs and training records, preparing product documentation, maintaining document systems, and training staff on documentation and labeling processes. The ideal candidate has a BA/BS and 3–5 years in document management.

Qualifications

• BA/BS degree plus 3–5 years related experience in document control.
• Knowledge of FDA regulations, GMP/GLP, and training records review.
• Strong written and verbal communication; detail oriented and organized.
• Ability to manage multiple documents and meet deadlines under pressure.

Responsibilities

• Review and approve GMP/GLP documentation to support timely product releases.
• Audit SOPs, training records, and other documents as needed.
• Assist in preparation of product documentation and change control packages.
• Maintain, proofread, and organize internal documents and systems.
• Provide training on documentation and labeling processes.
• Coordinate with engineering and project teams on document changes.
• Route, release, or reject documents as appropriate for compliance.

Skills

Document management

FDA regulations

GMP/GLP knowledge

Audit

SOPs

Training

Attention to detail

Communication

Time management

Education

BA/BS degree

Tools

Word

MS Office

Document management systems

Job description

Position Title: Document Control Specialist

Work Location: Round Lake, IL 60073

Assignment Duration: 3 Months

Work Arrangement: 1st Shift - 8AM to 5PM - Wednesday to Sunday

Job Details

• Review and approve GMP/GLP Manufacturing and related documentation to support timely product and system release.
• Conduct internal audit of SOP s, 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.
• 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, proofread, and change as needed Standard Operating Procedures

Qualifications

• 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.