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Location
Fremont, CA, United States
Posted on
Apr 08, 2021
Profile
We are seeking a Technical Writer for a very important client.
This candidate will work closely with cross functional teams to write, edit, review and finalize technical documents to support design transfer activities.
Key Responsibilities:
Technically strong to work independently with R&D and various scientists to create and transfer technical knowledge from an early Design Control phase into brand new work instructions.
Designs a new layout for SOPs relating to Manufacturing production/process instructions, policies, and procedures
Reviews technical literatures and published materials and recommends revisions or changes in scope, format, and content. Maintains records and files of work and revisions
Creates part numbers and Bill of Materials into the Material Resource Planning (MRP) software
Organizes large amounts of technical information utilizing Advanced MS Word and Excel functions as well as manage a large number of technical documents simultaneously.
Standardizes and streamlines documents and documentation system in coordination with chemists and managers
Closely interacts and builds effective relationships with people across site to promote quality, consistency and compliance
Familiarity with using a document routing, approving and tracking systems (e.g., MasterControl)
This candidate will work closely with cross functional teams to write, edit, review and finalize technical documents to support design transfer activities.
Requirement:
The ideal candidate will possess the following qualifications:
Minimum Requirements/Qualifications:
Bachelor?s degree in a scientific discipline with Minimum of 3-5 years of technical writing experience.
Experience in using a Document Management System as a Technical Writer
Familiarity with SAP/ ERP system.
Familiarity with Design Control
Must be computer literate and competent in PC based software such as Office 2010 Professional (Word, Excel, Access, and PowerPoint).
Proficient with 55 wpm minimum typing speed.
Knowledge of ISO 13485, FDA QSRs and GMP is preferred.
Good skills at alpha and numeric sequencing & filing.
Proofreading and editing skills, and an aptitude for numbers and detail oriented work requiring a high degree of accuracy.
Proactive in suggesting improvements in workflow.
Must have excellent customer service and listening skills.
Basic arithmetic skills including the ability to calculate figures and amounts and to interpret the data.
Able to sit, stand and/or use keyboard for long periods of time.
Must have the skills to work as a strong contributor in a team effort.
Demonstrate good flexibility with changes to working environment and deliver high quality results in a high-pressured deadline oriented environment
Experience in preparing manufacturing documents including SOPs, specification sheets and worksheets.
Experience in IVD Manufacturing preferred, but not required
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