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Specialist/Technical Writer
Location: Lake Forest, IL
Duration: 4 months
Description:
Primary Function:
Reporting to the Remediation Manager for Quality Systems, the Documentation Specialist will be responsible for reviewing and writing pharmaceutical/medical documentation (e.g. batch records, specifications, procedures, reports, SOPs, etc.) to provide clear and correct instructions for site processes and procedures. Will be responsible for the review and assessment of site documentation to ensure synchronization of content and format with corporate documentation. Will be responsible for identification and recommendation of best industry practices for documentation format. Will participate in transition from paper-based to electronic record keeping strategies. Will identify and provide recommended corrective actions for site documentation activities.
Major Duties and Responsibilities:
Review, edit or develop documentation (e.g. batch records, specifications, procedures, reports, SOPs, etc.) connected to specific project timelines. Assist in strategy development to transition to electronic documentation platform. Review and assess site documents to ensure compliance with corporate documents. Make recommendations for documentation content and format to support employee understanding of batch records, specification, procedures, and SOPs, etc. Support transition to electronic documentation platform. Identify commonalities and linkages in different documents to optimize common remediation activities. Active member of the remediation team to rectify the documentation gaps identified in the gap assessments working within a cross functional team which may include R&D, Quality, Manufacturing, Engineering, Regulatory Affairs, and Documentation Control. Assures compliance to all regulatory standards Travel to other Company sites as needed. 
Skills/Experience/Education:
A Bachelor's Degree is required, preferably with an educational background in science, engineering, manufacturing, or business in order to interact effectively with resources experienced in Manufacturing, Engineering, and Quality Assurance.
Experience in technical writing and/or procedure development, preferably in FDA regulated environment. Excellent communication skills and attention to detail Proficient with Microsoft Office (Excel, Word, Powerpoint). Visio preferred.
Capable of organizing data from multiple sources, extracting key information and writing reports and summaries Demonstrated ability to write logically and consistently Strong critical thinking and problem solving skills Resourceful and innovative approach Ability to work cross-functionally

A Bachelor's Degree is required, preferably with an educational background in science, engineering, manufacturing, or business in order to interact effectively with resources experienced in Manufacturing, Engineering, and Quality Assurance

Experience in technical writing and/or procedure development, preferably in FDA regulated environment. Excellent communication skills and attention to detail Proficient with Microsoft Office (Excel, Word, Powerpoint). Visio preferred.