RESPONSIBILITIES & ACCOUNTABILITIES

  • Responsible for DC, management of Document Control Request process, and maintenance of quality records (electronic and hardcopy files).
  • Responsible for set up, configuration, validation and implementation of electronic document management system.
  • Responsible for training department power users to use newly implemented electronic document management system.
  • Operates data capture technology to upload/import electronic documents into document management system.
  • Responsible for management activities related to personnel qualification and training, as well as ensures maintenance of automated and manual training documentation and personnel files.
  • Performs periodic reviews of controlled documentation and assessments of internal files.
  • Performs and participates in QA activities that include, but not limited to the following:

 

  • Audit activities, including planning, scheduling, monitoring and documentation
  • TMS software qualification and monitoring all the computer system validation activities
  • Batch records issuance
  • Change controls issuance and monitoring
  • Equipment database verification and hard copies filing
  • Log book issuance for production and QC equipment
  • Involved in the development, review and revision of procedures in accordance with the QMS.
  • Performs other departmental activities as needed and upon request

 

EDUCATION & EXPERIENCE

  • Requires Associate degree and 3 to 5 years of experience in DC/ QA activities, or an acceptable combination of education and experience.
  • Previous experience setting up, qualifying and training working personnel to use electronic document management systems (similar to Trackwise, LIMS, Livelink, Master Control) is essential.
  • Experience in medical device, pharmaceutical and/or clinical research industry preferred.
  • Working knowledge of regulations, standards and guidelines related to quality in cGMP environment.
  • Excellent written and oral communication, attention to detail, organizational and planning skills.
  • Proficiency with Microsoft Word
  • Ability to perform and maintain quality work while prioritizing and managing multiple deadlines.
  • Ability to work with different departmental designees on documentation-related activities.

This is a full-time position requiring 40 hours of work per week Monday through Friday

If you’re interested in joining a diverse team where you can make a difference, please contact us at

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