Quality Documentation & Technical Writer

We are looking for a skilled Quality Documentation & Technical Writer to support clients in developing, organizing, and maintaining high-quality controlled documents that align with ISO, GMP, FDA, and other regulatory requirements. This role focuses on creating clear, accurate, and compliant documentation such as SOPs, work instructions, validation documents, training materials, and quality manuals. The ideal candidate has strong writing abilities, excellent attention to detail, and a solid understanding of quality systems within regulated industries. You will collaborate closely with QA, operations, engineering, and regulatory teams to ensure all documents meet compliance standards and support efficient daily operations. Key Responsibilities Develop, revise, and maintain controlled documents including SOPs, policies, forms, templates, batch records, and quality manuals. Support document lifecycle management, ensuring timely updates, version control, and compliance with QMS requirements. Work with subject matter experts to translate technical concepts into clear, structured, and user-friendly documents. Prepare validation documentation such as URS, IQ/OQ/PQ protocols, reports, and risk assessments. Ensure all documents comply with FDA, ISO, GMP, and industry-specific guidelines. Assist with internal and external audit preparation by providing accurate and well-organized documentation. Develop training materials and support onboarding for new QMS or process changes. Recommend improvements in documentation structure, formatting, terminology consistency, and workflow efficiency. Support clients transitioning from paper-based systems to electronic documentation or QMS platforms. Qualifications Bachelor’s degree in Life Sciences, Technical Communication, Engineering, or a related discipline. 2–6 years of experience in technical writing, documentation management, or quality systems support. Strong understanding of ISO standards, GMP regulations, and quality documentation structure. Excellent written communication skills with exceptional attention to detail. Experience working with Document Control or QMS platforms. Ability to work with cross-functional teams and translate technical information clearly.Ability to work with cross-functional teams and translate technical information clearly. Preferred Skills Experience in pharmaceutical, medical device, biotech, or chemical industries. Knowledge of validation documentation, CAPA processes, and risk assessments. Familiarity with templates, style guides, and controlled documentation frameworks. Ability to manage multiple projects simultaneously in fast-paced environments. Why Join Us? Work closely with industry-leading companies across regulated sectors. Build expertise in quality systems, compliance documentation, and regulatory requirements. Engage in meaningful projects that improve operational quality and inspection readiness. Opportunities for professional growth, specialization, and leadership roles. Collaborative team environment with consistent support and development opportunities. #J-18808-Ljbffr Efficient Auditing