Senior Specialist, Quality Assurance

4 days ago


MagstattleBas, Grand Est, United States Hispanic Technology Executive Council Full time
Job Summary

We are seeking a Senior Specialist, Quality Assurance to join our team at Cardinal Health. The successful candidate will be responsible for ensuring the quality of our products and services, developing and implementing quality policies and procedures, and providing oversight of production/manufacturing activities.

Responsibilities
  • Perform all quality review and approval/release decisions at an FDA-regulated drug manufacturing facility
  • Handle CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls
  • Establish and report metrics related products and processes as deemed necessary by the Regional Quality Manager (RQM)
  • Ensure the site manufactures products to meet the requirements of 21 CFR 212 (CGMP)
  • Handle and ensure quality of documentation (control, retention, and archival) to support CGMP activities
  • Engage and collaborate with operations department to drive quality system and CGMP requirements
  • Perform product release activities per CGMP requirements
  • Monitor CAPA in investigations and close when completed or escalate (if necessary)
  • Perform aseptic review of the site with operations and document results
  • Report quality system issues to the RQM and others as necessary
Requirements
  • Bachelor's degree in related field, or equivalent work experience, preferred
  • 2-4 years of experience, preferred
  • Proficiency with MS Excel and MS Word
  • Effective written and verbal English communication skills
  • Strong attention to detail
  • Ability to lift between 30-45 lbs.
  • Pharmaceutical or medical device experience a plus
  • ISO experience a plus
Work Environment

The primary work environment consists of a manufacturing pharmacy which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards.

What is Expected of You
  • Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
  • Works on projects of moderate scope and complexity
  • Identifies possible solutions to a variety of technical problems and takes action to resolve
  • Applies judgment within defined parameters
  • Receives general guidance and may receive more detailed instruction on new projects
  • Work reviewed for sound reasoning and accuracy


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