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Technical Writer I / Pharma Manufacturing / REMOTE WORK

Company: Pioneer Data Systems Inc
Location: Newbury Park
Posted on: November 23, 2021

Job Description:

Our client, a world-leading Pharmaceutical Company is currently looking for a Technical Writer I / Pharma Manufacturing / REMOTE WORK to join their expanding team. Position Details: Job Title: Technical Writer I / Pharma Manufacturing / REMOTE WORK Duration: 06 months contract, extendable up to 36 Months Location: Remote Note: The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract. You may participate in the company group medical insurance plan Job Description: Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at the client. In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to the client, its operations, or its staff.--- ***REMOTE*** Owns and Manages Change Control Records. Owns and Manages Deviations, and Lead Root Cause Analysis. Develops, writes, edits, and formats materials such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical and business process documentation. When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality. Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis. Additionally, this position will be required to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of media (e.g., CD, intranet, on-line training, etc.); Job Requirements:Skills: MS Office expertise; previous technical writing experience; regulated environment experience; document version control experience; excellent communication/writing skills Responsibilities: Own and manage change control records Own and manage minor and major deviation records and lead root cause analysis sessions Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended. Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis. Incidental travel might be required. Authority Ability to apply risk-based approach, making decisions and escalating issues appropriately Outputs Contribute continuously improving the level of GDP compliance in Global Distribution Supply Chain. Competencies Effective communication skills at multiple levels, areas and countries Ability to apply risk-based approach, making decisions and escalating issues appropriately Analytical and evidence-based approach to problems. Ability to see the connection between issues, to identify common factors and bring the correct stakeholders together. Pro-active in proposing solutions and driving tasks to completion Works autonomously, respecting deadlines Works with a high degree of discipline and attention to detail Requirements: Bachelor's degree or equivalent in Life Sciences + 2 years' experience in GMP / GDP compliance In the absence of a Life Sciences degree, 4+ years' experience in GMP / GDP compliance Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice. Fluency in English, Dutch-preferable Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. TrackWise, EDMQ, etc) Experience in audit / inspection support Technical writing skills Top 3 must have skill sets GMP experience Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice. Experience in Technical writing, regulated environment experience ( Food industry is acceptable); document version control experience. Works autonomously, respecting deadlines Works with a high degree of discipline and attention to detail Day to Day responsibilities: GMP experience Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice. Experience in Technical writing, regulated environment experience ( Food industry is acceptable); document version control experience. Works autonomously, respecting deadlines Works with a high degree of discipline and attention to detail Employee Value proposition: The person will work with supply chain global distribution. You will work with quality records and product theorization.

Keywords: Pioneer Data Systems Inc, Los Angeles , Technical Writer I / Pharma Manufacturing / REMOTE WORK, Engineering , Newbury Park, California

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