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Analytical Lab Technical Writer

Company: Thermo Fisher Scientific
Location: Greenville
Posted on: August 11, 2019

Job Description:

Job DescriptionJob Title: Technical Writer III / PDS Analytical DevelopmentEffective Date: Last Modification Date: June 10, 2019Summary:Supports the PDS AD Laboratory with writing, editing, tracking of standard operating procedures, analytical specifications, investigation reports, and deviations. Generating ideas and recommendations for system improvement and assistance for scientific writing.Essential Functions:Technical writing support for deviation and investigation report writing, as well as Corrective And Preventive Action plans (CAPAs) in accordance with GMPs. Facilitates the development and standardization of quality products through participation and representation on group and department level project teams. Drafts and revises Analytical Development (AD) protocol, method, and report templates along with other documentation necessary to ensure the qualification of methods. Prepares documents and facilitates circulation for review and approval to meet project timelines. Edits documents for grammar, spelling, format, and style according to established guidelines. Creates necessary guidelines to standardize document content (eg protocols, reports, analytical standards, SOPs, etc ). Consults with technical personnel on process requirements and specifications as well as consults relevant SOPs to assure compliance. Completes necessary support tasks for document issuance. Obtains information in a timely manner, manages document changes from many sources, prioritizes work to meet tight timeframes, builds consensus with multiple reviewers and works to meet the department Right First Time and On Time Delivery metrics. Participates in continuous improvement projects. Develops documentation processes. Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. Coordinates and leads writing of SOPs, policy manuals, and other instructional documents. Conducts training of AD staff on new or revised processes associated with document management systems. Coordinates the development of training curricula. Assistance with training and guidance of Analytical Development personnel as appropriate. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.Education:Associates or Bachelor s degree, preferably in chemistry or biological sciences.Experience:Prefer a minimum experience of 5-7 years. If Bachelor's degree, 5 years of related experience; Associate's degree typically requires 7 yrs experience.Equivalency:Equivalent combinations of education, training, and relevant work experience may be considered.Competencies:Excellent knowledge and understanding of the current good manufacturing practices. Knowledge of quality and laboratory systems is essential. Excellent understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs. Excellent problem solving skills and logical approach to solving scientific problems. Must possess excellent organizational and interpersonal skills, strong oral and written communication skills, and the ability to multi-task and adjust to changing priorities. Applicant must have the ability to work independently and meet strict deadlines. Proficient with Microsoft Office (especially MSWord and MSExcel). Excellent interpersonal and communication skills (both oral and written). Good presentation skills to present information to customers, clients, and other employees. Ability to read, analyze, and interpret technical procedures and governmental regulations. Ability to write standard operating procedures and policy manuals. Ability to respond to complex inquiries or complaints from customers or regulatory agencies.Physical Requirements:Position requires ordinary ambulatory skills and physical coordination enough to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.
Disclaimer: This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.FOR HR USE ONLYJob Code(s): Please indicate both the site location and the job code Job Category: Categories to be determined by Corporate HRFLSA Status (US Only): Non ExemptIf you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, for further assistance. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Associated topics: administrative, administrative and operational assist, administrative assist, assistant, executive assistant, operational assist, operator, production, shift, support Associated topics: administrative, administrative and operational assist, administrative assist, assistant, executive assistant, operational assist, operator, production, shift, support Associated topics: administrative, administrative and operational assist, administrative assist, assistant, executive assistant, operational assist, operator, production, shift, support

Keywords: Thermo Fisher Scientific, Greenville , Analytical Lab Technical Writer, IT / Software / Systems , Greenville, North Carolina

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