• Quality Person In Plant

    Insight Global (Gaithersburg, MD)


    Job Description

    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. Responsibilities Include:

     

    • 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 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.

     

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

     

    Skills and 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 invesitgations, deviations, change controls for QA on the floor support.

     

    -Good attitude -CliniMACS Prodigy Instrument Experience

     

    -CAR T experience is strong preferred

     

    -Previous partnership or working with CMO / EM partners