Quality Assurance Specialist

1 week ago

Newark, United States Rangam Full time

Job Title: Quality Assurance Specialist IV


Job Summary:

  • The Specialist IV provides compliance support or oversight for operational functions.
  • This includes technical writing and authoring of quality system records such as laboratory investigations, deviations, CAPA, and change controls pertaining to operational functions supported by Quality Systems & Compliance (e.g., Quality Control).
  • Conducts investigations for Laboratory Investigation Reports (LIR) and deviations via effective root cause analysis.
  • Monitors completion of the quality system records and provides escalation to management, as needed.
  • Generates and analyzes metrics for operational activities, including but not limited to laboratory investigations and invalid assays and other laboratory operation parameters as appropriate.
  • Authors and/or revises other controlled documents such as procedures, methods, work instructions, protocols, and reports as applicable.
  • Ensures personnel compliance of corresponding training programs for supported operational functions.

Essential Duties:

  • Provide technical writing in support of operational functions, such as Quality Control (QC).
  • Responsible for authoring Out of Specification (OOS) and anomalous event laboratory investigations, deviations, CAPA, and change controls.
  • Perform risk analysis as needed to determine severity, likelihood of recurrence when triaging events and/or conducting investigations.
  • Conduct investigations thoroughly for OOS events according to the phase-based approach per FDA and Annex guidelines.
  • Investigate deviations to identify root cause and contributing factors and in parallel assess impact to patients, product quality, data integrity, validated state, and regulatory compliance.
  • Identify and develop relevant and effective CAPA.
  • Address impact to systems, processes, product, and any regulatory requirements when authoring change controls.
  • Prioritize and monitor completion of lab investigations, deviations, CAPA, and change controls.
  • Maintain expected standards with concise technical writing using correct grammar, detailed and accurate information, to be completed within established timelines.
  • Generate and analyze metrics as applicable.
  • Manage and author change controls related to qualification, modification, and/or decommissioning of equipment.
  • Possess a strong understanding of data integrity principles.
  • Ensure compliance of personnel with corresponding training program(s).

Education

Minimum Required:

  • Requires a Bachelor’s degree

Preferred:

  • Master of Science in related field is highly desired.
  • For Bachelor’s degree, it is preferred to be in Biochemistry, Biology, or a related pharmaceutical-biotechnology discipline.

Experience

  • A minimum of 3 years work experience within a GMP environment working with small and/or large molecules.
  • Experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fischer, UV and HPLC (Waters Empower software is preferred), and Relative Potency Assay.
  • Solid technical training and troubleshooting experience are essential.
  • Strong understanding of data integrity principles within a GMP environment is required.
  • Expertise in use of Microsoft Office applications.

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