Quality Assurance Specialist in Plainsboro Township, NJ at Integrated Resources, Inc

Date Posted: 6/24/2020

Job Snapshot

Job Description

  • Review all electronic documents submitted to document control for correct formatting, spelling and clarity of text before releasing as approved documents
  • Maintains revision and approval status of all documents
  • Maintains hard copies of all approved documentation
  • Maintains appropriate form templates for access
  • Updates computerized documents with data from change control documents and maintains archive of changed ISO/FDA controlled documents
  • Manages circulation of documents for management approval
  • Tracking, follow-up and implementation of, including but not limited to, ECOs, DCOs, MCOs, ECRs and DCRs.

  • Minimum of 1-2 years' experience in document management using electronic document management systems or with manual systems using electronic document storage
  • Minimum of 1-2 years' experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device, diagnostics or pharmaceutical industries.
  • Familiarity with FDA regulations and ISO series of quality standards preferred
  • Capable of both written and verbal effective communication skills including presentations as assigned.
  • Proficient in the Microsoft Office suite of products
  • Proficient in Agile Document Management System
Solid organizational and document management skills