Manufacturing Operations Compliance Expert

2 days ago


Fremont, California, United States Catalyx Full time
Job Description:

Catalyx seeks a skilled Compliance Specialist to manage change control records and lead projects in support of Manufacturing Operations. This position will support the monitoring and reporting of deviations, change controls, and improvement projects. The role involves owning and maintaining change control records, CAPAs, and Periodic Review documents, as well as SOP revisions. The ideal candidate will identify areas for Continuous Process Improvement and apply operational excellence tools to reduce process variability and deliver measurable efficiency gains.

Key Responsibilities:
  • Manage change control records and lead projects in support of Manufacturing Operations.
  • Monitor and report deviations, change controls, and improvement projects.
  • Own and maintain change control records, CAPAs, and Periodic Review documents, as well as SOP revisions.
  • Identify areas for Continuous Process Improvement and apply operational excellence tools.

Requirements:
  • Bachelor's Degree with a focus on Bio-pharmaceuticals.
  • Possesses knowledge in the area of manufacturing bio-pharmaceuticals.
  • Experience in managing simple to moderate projects, and CAPA.
  • Possesses knowledge of cGMP systems and of regulations from different regional jurisdictions.
  • Experience leading meetings, and mastery of techniques to keep meetings effective and team on task.
  • Experience writing technically (e.g. SOPs or protocols, or deviations, etc.).

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