Our client, a leading Life Sciences company, is hiring a Documentation Specialist.

Work Location: Kenosha County, Wisconsin

Summary:

Seeking a Documentation Specialist for a 12-month contract with potential for extension or conversion. This role requires on-site work during weekday day shifts and offers up to $50/hour. The position focuses on technical writing within a GMP-regulated environment, supporting compliance and documentation needs.

Responsibilities:

• Prepare, revise, and format controlled documents such as SOPs, protocols, test methods, and reports in alignment with regulatory standards and templates.
• Engage daily with subject-matter experts from various departments to collect and clarify technical information for documentation.
• Contribute to remediation and gap assessments for Design History Files as required.
• Ensure all documentation meets traceability, consistency, and compliance with relevant FDA, EU, and data integrity regulations.
• Oversee document review and approval processes using electronic document management systems.
• Participate in meetings, present draft documents, and efficiently incorporate feedback while maintaining professional relationships.
• Support the creation and maintenance of documentation for combination products and related regulatory requirements.
• Maintain high standards of accuracy and clarity in all written materials, ensuring alignment with industry best practices.

Qualifications:

• Bachelor’s degree in engineering (Biomedical, Mechanical, Chemical preferred), Life Sciences, Technical Communication, or a related STEM field.
• At least five years of technical writing experience in FDA-regulated pharmaceutical, biotechnology, medical device, or combination product settings.
• Demonstrated expertise in authoring FDA-compliant SOPs, protocols, test methods, work instructions, and reports within cGMP or QSR environments.
• Proven ability to interview subject-matter experts and translate complex technical concepts into clear, compliant documentation.
• Strong interpersonal skills, including professionalism, courtesy, adaptability, high emotional intelligence, and effective communication.

Published Category: Quality & Validation