Senior Technical Operations Specialist

3 weeks ago


Boston, Massachusetts, United States Connexion Systems & Engineering, Inc. Full time
Senior Technical Operations Specialist

We are looking for a highly skilled Senior Technical Operations Specialist to join our team at Connexion Systems & Engineering, Inc. in Boston.

The successful candidate will be responsible for owning, driving and managing CMC CAPAs and change controls from initiation, assessment and planning, execution, and closure.

This is a full-time position that offers a competitive salary of $125,000 - $155,000 per year, depending on experience.

The ideal candidate will have 6+ years of progressive experience in pharmaceutical development and manufacturing, with a strong background in technical writing and performing event investigations in a GMP-compliant environment.

The Senior Technical Operations Specialist will own deviations, CAPA, Effectiveness Check (EC) and Risk Assessment records in electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved.

This role requires a high-level of schedule flexibility to support our cell manufacturing clinical hours of operation and timelines.

Key Responsibilities:
  • Own, drive and manage CMC CAPAs and change controls from initiation, assessment and planning, execution, and closure.
  • Owning deviations, CAPA, EC and Risk Assessment records in electronic Quality Management System (eQMS).


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