Technical Writer - Tech Transfer and Validation

Our Business Adare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services. Our clients range from growing biotech firms advancing groundbreaking clinical trials to established pharmaceutical companies producing high volumes of approved, widely used medicines. By combining top talent from the life sciences industry with modern research and manufacturing technologies, Adare enables clients to deliver potentially lifesaving medicines in more easily consumable formats - particularly for patients such as infants or the elderly. This is the meaning behind "Transforming Drug Delivery - Transforming Lives." Our Culture When it comes to being an employee of Adare, although we are located across multiple countries and come from diverse backgrounds, we work together toward a common purpose. Supported by leadership that is experienced and highly regarded in the industry, we are paving the way for a brighter and better future by attracting top talent from both within and beyond the CDMO space. In addition to delivering high-quality results for our external clients, we foster a collaborative, client-centric culture internally - one where employees support one another, share knowledge, and encourage each other to bring their best selves to work each day. Why Come to Adare? Adare is Private Equity owned and poised for growth. Employees are provided with internal development opportunities to progress within the organization, enhancing their professional skills and industry knowledge through Adare's investment in their growth. We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry, formulations, analytical research and development, finance, supply chain, sales, marketing, project management, human resources, and environmental health and safety. Our benefits package is highly competitive, offering medical, dental, and vision coverage; a retirement plan with company match, paid time off and company holidays, tuition reimbursement with no waiting period, life insurance, pet insurance, Flexible Spending Accounts (medical and dependent care), and disability coverage. Position Technical Writer Location Vandalia, Ohio Summary 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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