ASD - Quality Assurance Specialist II in San Diego, CA at Apex Life Sciences

Date Posted: 4/4/2018

Job Snapshot

Job Description


Duties

  • Review and approve Triage, INRatio, LDX, and Meter Device History records for device release from the site; and others as required
  • Work with groups within the organization to get corrections and clarifications to Device History Records
  • Prepare labeling for all finished product and perform labeling of product.
  • Utilize Access Database for tracking receipt, review and correction of Batch Records.
  • Utilize JDE to perform transactions and verify product information.
  • Generate Certificate of Conformance / Certificates of Analysis for Final Product.
  • Prepare approved MRPs for filing in designated file rooms.
  • Perform other duties & projects as assigned
  • Carries out duties in compliance with established business policies.
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
  • Responsible for exhibiting professional behavior with both internal/external business associates that Quality Assurance Specialist I Revised: March 2015 reflects positively on the company and is consistent with the company’s policies and practices.
  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
  • Perform other duties & projects as assigned

Education/Experience

  • High School Diploma or equivalent. Bachelor’s Degree preferred
  • 2-4 years related experience
  • Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic
  • Knowledge of Quality System Regulations
  • Experience with MS Office
  • Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor
  • Must be detail-orientated, self-motivated and available for flexible scheduling
  • Strong communication, problem solving and motivational skills
  • Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervision
  • Ability to interact effectively with all levels of the organization and perform multiple tasks in a fast paced environment.



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