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Quality Assurance Specialist IV

4 weeks ago

Newark, New Jersey, United States Meet Full time

Job Summary:

We are seeking a highly skilled Quality Assurance Specialist IV to join our team at Meet. This role involves technical writing, conducting thorough investigations, and monitoring quality system records to uphold regulatory compliance and product integrity.

Key Responsibilities:

  • Provide compliance support for operational functions, particularly in Quality Control (QC), ensuring adherence to GMP standards.
  • Author and revise quality system records including Out of Specification (OOS) reports, laboratory investigations, deviations, Corrective and Preventive Actions (CAPA), and change controls.
  • Conduct comprehensive investigations for Laboratory Investigation Reports (LIR) and deviations, employing effective root cause analysis and risk assessment techniques.
  • Ensure personnel compliance with training programs relevant to supported operational functions, fostering a culture of continuous learning and improvement.
  • Manage and author change controls associated with the qualification, modification, and decommissioning of laboratory equipment, assessing impacts on systems and processes.
  • Maintain high standards of technical writing, ensuring all documents are clear, concise, and completed within established timelines.

Requirements:

  • Bachelor's degree in Life Sciences, Quality Assurance, or related field.
  • Minimum of 3 years in a GMP environment, with experience in quality assurance for small and/or large molecules.
  • Proficiency with a variety of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fischer, UV, HPLC (Waters Empower software preferred), and Relative Potency Assay.
  • Strong understanding of data integrity principles within a GMP framework.
  • Solid technical training and troubleshooting experience in quality systems.