Quality Person in Plant Job at Insight Global, Gaithersburg, MD

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  • Insight Global
  • Gaithersburg, MD

Job Description

Requirements:

  • Degree in a Science / Engineering related field required, with preferred focus or experience in pharmaceutical manufacturing.
  • Minimum 3-5 years’ experience in pharmaceutical manufacturing, with preference in cell and gene therapy manufacturing.
  • Previous experience within investigations, deviations, change controls for QA on the floor support.

Preferred:

  • CliniMACS Prodigy Instrument Experience
  • CAR T experience is strong preferred
  • Previous partnership or working with CMO / EM partners

Day to Day:

This position will perform manufacturing oversight of an external contract manufacturing organization producing a Phase II/III clinical CAR-T program as a person in plant. Additionally, this position will be responsible for supporting Johnson and Johnson and the CMO in the following activities:

  • On the Floor Technical Support and Issue Triage Support (i.e. rapid response to MFG issues, resolution, and communication / escalation)
  • Facility Oversight, including routine GEMBA walks, reporting of observations to CMO / Johnson & Johnson, and support in driving improvements where needed
  • Support in technical writing/review for product impact assessment, investigations / deviations and change controls.
  • Support in the execution and implementation of CAPAs.
  • Support in technical writing/review for batch records, SOPs, and other documents as needed.
  • Support in data transcription and analysis for manufacturing process and release data.

This position will be responsible for working with the contract manufacturing organization to drive improvements, oversee and support in manufacturing operations, ensure collaboration and communication, and oversee execution of tasks such as manufacturing investigations, change controls, batch record revisions, continuous improvement efforts and corrective and preventative actions.

Job Tags

Contract work,

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