The Technical Writer develops, revises, and manages controlled documentation using the OpenText System, ensuring compliance with GMP and company policies.
They collaborate with Quality, cross-functional teams, and engineers to ensure accuracy and clarity in SOPs, work instructions, forms, and training materials.
Additionally, they support LMS administration by creating curricula, maintaining training records, generating reports, and resolving discrepancies to support audits and compliance.
The role involves reviewing documents for formatting and technical accuracy, editing images/videos, and providing administrative support such as filing and coordinating site activities.
Qualifications include a bachelor's degree, 2+ years of relevant experience in a regulated industry, proficiency with LMS, OpenText, and Microsoft Office tools, and a solid understanding of GMP principles.
Strong organizational, multi-tasking, and interpersonal skills are essential. Salary ranges from $75,000 to $80,000.