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Quality Support
Category: Other
  • Your pay will be discussed at your interview

Job code: lhw-e0-90672888

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  Job posted:   Thu Jun 7, 2018
  Distance to work:   ? miles
  28 Views, 0 Applications  
Quality Support
Req Ref No: RPMAQS5
Location: Walpole, MA
Duration: 11 Months
Position Overview:
This is an individual contributor position that requires an individual with knowledge/experience utilizing document management systems and processes in a regulated environment, e.g., IVD, Medical Device, Pharma, Biotech, etc. The individual in this role will be responsible for assisting the documentation modification, translation and implementation activities among client cross functional team, Global Translation Service Team and China manufacturing facility.
In this role the individual will be responsible for coordinating China document management activities.
Specific responsibilities include:
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.
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:
A minimum of 3 years in an FDA regulated environment, (e.g., IVD, Medical Device, Pharma, Biotech, etc.)
A minimum of a 4 year college degree is preferred, although a combination of education/experience will be considered.
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
Fluency in Chinese (Mandarin) is highly desired
Prior experience with facility start-ups, or other major projects, e.g. documentation system implementation.
Prior experience working with translation services.
Project management experience is a plus.
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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