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Quality Analyst
Ref No.: 18-00803
Location: Raritan, New Jersey
Start Date / End Date: 06/11/2018 to 06/09/2019

We are seeking a Quality Analyst who will review executed device history records (batch records, testing records, forms, temperature charts, autoclave charts) to:

  • Verify the accuracy of the record.
  • Ensure the records are executed as required.
  • Ensure the records are compliant with Specifications/Requirements, Quality System Regulations, and GMPs.
  • Ensure compliance with established processes and procedures.

Other Duties:

  • Provides final approval of executed device history records.
  • Follows up with Operations or laboratory personnel to correct errors device history records.
  • Generates Nonconformance records in the electronic Nonconformance Management system when nonconformances are identified during a device history record review.
  • Prepares and verifies the accuracy of Certificates of Analysis and Certificates of Manufacturing.
  • Uploads approved CoAs and Antigrams to applicable electronic systems.
  • Supports investigations for customer complaints by performing a batch review of the impacted area.
  • Files completed Device History records and Device History files.
  • Assists in the archiving of Device History Files and other quality records.

Requirements:

  • Bachelor's Degree in Medical Technology or equivalent scientific field is preferred and/or a minimum of 3 years professional experience in an FDA-regulated environment or equivalent industrial experience.
  • Understanding and application of scientific principles and methodologies with regard to medical technology, and life science.
  • Thorough knowledge of FDA, QSR, ISO and GMP requirements for pharmaceuticals and medical devices.
  • Additional skills required for this position include the following: the ability to schedule workload to meet department and team goals with minimum supervision, good organizational and time management skills to meet multiple and changing priorities, good written and verbal communication skills, the ability to interact with various department personnel.
  • Strict attention to detail and the ability to focus attention and work in a fast-paced environment are key to success in this position.