Technical Writer - Tech Transfer and Validation

Technical Writer

The Technical Writer reports to the Director of Technical Services and Validation. The essential job function is to assume responsibility for all documentation and procedural activities associated with commercial production and technical transfers, as well as support documentation needs of the R&D scientists. It includes monitoring of existing documents (including, but not limited to: Batch Records, SOPs, OIMs), identifying opportunities for improvement, and implementing both process and/or procedural improvements to further the efforts in the Manufacturing group to continuously improve. It also includes project execution within the department, such as product transfers or changes, in addition to other daily functions needed or requested by the Director of Validation and Technical Services.
Responsibilities
Provide documentation services to the Technical Services department including writing, revising, formatting, processing, filing, and maintaining documents, including electronic files. These documents include, but are not limited to batch production records, SOPs, protocols, and reports.
Be able to draft incident reports, investigation reports, or other quality event (QE) reports.
Support Quality Systems for the Technical Services Department, including CAPA, Change Control, QE tracking/trending.
Work with technical experts to identify and document appropriate Corrective Action, Preventative Action (CAPA) as needed. Responsible for completion of appropriate CAPA documentation.
Act as Electronic Quality Documentation Management System Subject Matter Expert (SME) for the department, assisting and training others as needed.
Responsible for the SOP biennial review process for Technical Services, including SOP revisions within the established timelines, as needed.
Preparation of the Validation Section for Periodic Quality Reviews (PQRs), including data collection, document preparation, and identification of applicable CAPAs as necessary.
Support the process for the generation of scientific papers and technical documentation to promote Adare Technologies and support marketing initiatives
Support the Technical Services and, as appropriate, the Research & Development depts. by drafting Papers, Posters, Whitepapers, Presentations, Webinars, etc.
Support all Continuous Improvement efforts within the department.
Support and promote Safety and cGMP programs, ensuring strict conformance to all current FDA and cGMP guidelines.
Follow and observe all regulatory requirements (GMP's, ISO, FDA, internal policies) applicable to area of responsibility.
Uphold Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.
Perform other tasks as required.
Experience, Education, and Skills Required
Minimum High School diploma or equivalency with three to five years of experience technical writing and/or procedure development, preferably in FDA regulated environment OR Bachelor's degree with two to three years of experience technical writing and/or procedure development, preferably in FDA regulated environment.
Proficient with Microsoft Office (Excel, Word, PowerPoint).
Capable of organizing data from multiple sources, extracting key information and writing reports and summaries
Demonstrated ability to write logically and consistently
Strong decision making and problem-solving skills
Excellent interpersonal written and oral communication skills
Ability to thrive in a dynamic and fast-paced environment.
Able to prioritize duties and manage multiple projects from start to finish with minimal supervision.
Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision.
Exceptional attention to detail and excellent organizational skills.
Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.
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