MQA Specialist I - Night Shift (12 Hrs) (5 Openings)

Employment Type

: Full-Time

Industry

: Healthcare - Nursing



Position Summary

The Manufacturing Quality Assurance (MQA) Specialist I is responsible for providing quality oversight to all manufacturing and packaging areas to ensure product quality and SOP/GMP compliance at the Cleveland Manufacturing Facility. Works closely with Production personnel to complete on-the-floor, in process batch record review, resolve all batch related issues or escalate to the Quality Assurance Supervisor as appropriate, and ensure good documentation practices are being followed.

Key Responsibilities

  • Required to be on the floor and present to provide quality oversight for all critical manufacturing processes.
  • Required to become and maintain Gown and AQL Visual Inspection Qualification.
  • Addresses daily quality concerns and questions related to operating and environmental issues.
  • Clearly communicates complex issues to Management personnel.
  • Work closely with Production personnel to complete in-process batch record review, resolve batch related issues with guidance from MQA Supervision.
  • Assist in analysis of inspection rejects; assist in root cause analysis and implementation of CAPAs.
  • Perform and document assessments of aseptic behavior inside the aseptic manufacturing area during filling, capping, and lyophilizer loading/unloading activities. Provide real time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation.
  • Complete monthly inspections of the physical conditions of the manufacturing support areas and report issues to MQA supervision.
  • Provide regular updates about aseptic behaviors to the production department, support groups and site leadership.
  • Participation in gathering of data needed for the Annual Product Review.

Requirements

  • A.S. degree required
  • B.S. in Life or Physical Science preferred
  • 1+ years of professional experience
  • Knowledge of a GMP production facility and/or inspection processes required
  • Ability to critically evaluate and troubleshoot complex problems and articulate clearly to management is essential
  • Well-organized and detailed oriented professional, with strong verbal and written communication skills
  • Quality or Pharmaceutical certifications is a plus

Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients' quality of life. Together with us, you can help lead the fight against bacterial infections.

Read more about Xellia Pharmaceuticals here



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