Title: Technical Writer
MS Office,Excel, Word, Powerpoint
This is an individual contributor position that requires an individual with knowledge/experience of writing operational procedures in a regulated environment, e.g., IVD, Medical Device, Pharma, Biotech, etc.
The individual in this role will be responsible for writing, reviewing, verifying operational procedures to be implemented in the newly established China manufacturing facility.
In this role the individual will be responsible for writing, reviewing, verifying operational procedures to be implemented in the newly established China manufacturing facility.
Specific responsibilities include:
Verify translated Chinese documents against original English documents to ensure translation accuracy.
Maintain a comprehensive library of technical terminology and documentation.
Review, edit and format documents to ensure compliance with GDP and formatting requirements.
Organize document source files and compile document metadata information to load documents through bulkload process.
Work with IT and China documentation specialist to manage document bulkload and manual upload process.
Create BOM and routings for the new Shanghai facility.
Update reference list for each document using document naming convention master list.
Assist other team members to coordinate document update activities with all project functions, e.g., Manufacturing, Technical Operations, Engineering, Quality, etc.
Assist other team members to coordinate translation activities with Global Translation Agency.
Assist in compiling KPI data to provide weekly/monthly/quarterly status report to management
Required Knowledge/Skills, Education, and Experience
Experience: A minimum of 1 years in an FDA regulated environment, (e.g., IVD, Medical Device, Pharma, Biotech, etc.)
Education: A minimum of a 4 year college degree is preferred, although a combination of education/experience will be considered.
Fluency in Chinese (Mandarin, simplified) and be able to read/write technical documents in Chinese.
Prior experience working in an FDA regulated environment and a thorough understanding of good documentation practices.
Advanced expertise in MS Office Suite, including Excel, Word, Powerpoint.
Prioritization, attention to details, multitasking, organizational skills, timeline driven and self-motivated
Ability to apply deductive reasoning and understand complicated issues.
Must be able to work collaboratively with other project team members.
Administrative experience with scanning, filing and organization
Accurately file and maintain the latest physical and electronic copies of all company documentation in accordance with regulations.
Preferred Knowledge/Skills, Education, and Experience
Prior experience with facility start-ups, or other major projects, e.g. documentation system implementation.
Proven experience working in a technical writing position.
Project management experience is a plus.
VIVA USA is an equal opportunity employer and is committed to maintaining a professional working environment that is free from discrimination and unlawful harassment. The Management, contractors, and staff of VIVA USA shall respect others without regard to race, sex, religion, age, color, creed, national or ethnic origin, physical, mental or sensory disability, marital status, sexual orientation, or status as a Vietnam-era, recently separated veteran, Active war time or campaign badge veteran, Armed forces service medal veteran, or disabled veteran. Please contact us at email@example.com for any complaints, comments and suggestions.
Recruiter name: Bhavya C ,Phone (847)807-6782 , Email: firstname.lastname@example.org
VIVA USA INC.
3601 Algonquin Road, Suite 425
Rolling Meadows, IL 60008
email@example.com | http://www.viva-it.com