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Job Details

Technical Writer Facilities Utilities GMP

Company name
PSC Biotech

Location
San Diego, CA

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PSC Biotech is a leading process consulting and contract engineering company. For over 20 years we have been engaged in providing laboratory support, project, process, engineering and validation support to top-tier pharmaceutical and biotech companies. Currently, we are looking for a technical writer to support one of our clients in San Diego, CA. The ideal applicant will have 2 years experience in pharmaceutical or biotech manufacturing, technical support or process engineering. Responsibilities: Primarily, writes, edits, and reviews cGMP facilities\/ utilities documents, Product Specifications, SOPs, and engineering related material in support of Process Engineering and\/or Manufacturing activities while maintaining standardized and consistent documentation practices for recording details of new processes. Maintains standardized language and documentation practices that allow for consistent execution of documents. Establishes and supports documentation practices that reduce review times and deviation by researching errors and inconsistencies in existing records and communicating effectively with appropriate personnel. Edits documents written by others to verify accuracy, consistency, grammar, and format. Interacts closely with Project Management, Manufacturing, and QA. Requirements: PREFER LOCAL Candidates. MUST HAVE BIOTECH\/ PHARMACEUTICAL\/ MEDICAL DEVICE industry experience. Willing to travel up to 20% to Seattle and San Francisco Bay Area, CA. Experience with facilities \/ utilities technical writing would be huge plus. Experience writing SOPs - Standard Operating Procedures. Minimum of Bachelor Degree; Preferred Chemical or Mechanical Engineering Degree Technical writing experience including manufacturing procedures and instructions Demonstrates knowledge of current Good Manufacturing Practice (FDA, EU and ICH) requirements and Quality Systems, with the ability to assess compliance risks. Demonstrates analytical problem solving skills. Demonstrates ability to explain complex concepts with clarity and simplicity. Demonstrates ability to perform detail-oriented work with a high degree of accuracy. Demonstrates strong verbal, written, and interpersonal communication skills. Demonstrates proficiency in Microsoft Office applications and Adobe Acrobat Professional. -To see more about this job please click the buttom below.

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PSC Biotech

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