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Quality Specialist
Quality SpecialistInsight Global • Morris Plains, NJ, United States
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Quality Specialist

Quality Specialist

Insight Global • Morris Plains, NJ, United States
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Requirements :

  • Minimum education level Bachelors degree in scientific field
  • Minimum of 5 years of experience working within quality manufacturing, preferably within external quality i.e. CMO or CDMOs
  • Strong in Root Cause Analysis in a Pharmaceutical environment
  • Change and Deviation management
  • Ability to work independently
  • Strong interpersonal and written / oral communication skills
  • Ability to quickly process complex information and make critical decisions with limited information in a complex and time-sensitive environment

Preferred :

  • Previous experience working on large molecule, CAR-T, cell therapy or advanced therapeutic areas
  • Experience working within quality systems
  • Day to Day :

    Our large Pharmaceutical client is seeking a Quality Person In Plant (QPIP) to oversee and support an external manufacturer within Advanced Therapeutics in Morris Plains NJ.

    Responsibilities of the Quality Person in Plant :

  • Acting as sponsor's representative and main point of contact for manufacturing decisions
  • Resolve manufacturing issues along with daily review of manufacturing investigations, change controls, and complaints
  • Work to drive compliance to limit non-conformances
  • Perform reviews of batch records, procedures, documentation, and audits
  • Adhere with cGMP requirements along with general safety policies
  • Compensation : $45-55 / hr

    Exact compensation may vary based on several factors, including skills, experience, and education.

    Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and / or other paid time off as provided by applicable law.

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    Quality Specialist • Morris Plains, NJ, United States

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