Technical Writer (Assoc, Int, Sr) Department: Technical Operations - Engineering and Automation Compliance
Summary: Performs all technical writer related tasks necessary for the creation and maintenance of quality GMP documentation in support of the Technical Operations Engineering and Automation Department.
Essential Duties and Responsibilities include, but are not limited to, the following: Collaborate with subject matter experts and key functional department personnel to ensure timely development and accurate content of GMP documents (e.g. standard operating procedures, system design documents, and work instructions).Perform retrospective assessment of computerized system administration activities and author the resulting reports.Maintain an awareness and understanding of current site document requirement, document control procedures, and good documentation best practices. Review internal GMP documents to ensure they are compliant with these expectations and suggest improvements.Manage and coordinate activities related to document creation using the Electronic Document Management System, including document initiation, workflow support, revision, and retirement.Conduct compliance review of electronic work tickets for adherence to Good Documentation Practices/Requirements.Facilitate cross-functional collaboration of cGMP documentation with technical experts and stakeholders to reach consensus and ensure document approval timelines meet business needs.Own and/or support GMP document-related Change Controls/CAPAs. Education and Experience: Associate Technical Writer: Requires BS/BA in Life Sciences, Engineering, English or related field or equivalent combination of education and experience.Technical Writer: Requires BS/BA in Life Sciences, Engineering, English or related field and 2 years of relevant experience or equivalent combination of education and experience.Senior Technical Writer: Requires BS/BA in Life Sciences, Engineering, English or related field and 5 years of relevant experience or equivalent combination of education and experience. Knowledge, Skills, and Abilities: Strong knowledge of Good Documentation Practices (ALCOA), ISPE Standards, GAMP5, and Documentation Management/Life Cycle guidance. Applies excellent collaboration skills, via multiple communication types, in a steady-paced environment. Strong writing and proofreading skills in a technical and scientific capacity. Ability to organize and author technically complex information into laymen suitable documentation. Ability to maintain keen attention to detail with a high regard for quality, efficiency, and processes.
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