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Quality - Specialist, QA Engineering

Company: Katalyst Healthcares & Life Sciences
Location: Warren
Posted on: May 17, 2023

Job Description:


  • Supports all activities for the QA Engineering group.
  • Support cross functional departments on risk identification, root cause analysis and investigative measures and support evaluation and implementation of a plan to mitigate process and/or product risks
  • Contribute to the writing, coordination, review, approval and maintenance of the Warren Risk Management Standard Operating Procedures (SOPs) and associated documentation.
  • Develop and maintain documentation to track key risk information and provide risk reporting to include both quantitative and qualitative risk information.
  • Develops and Maintains Quality Metrics to monitor compliance
  • Evaluate and report key performance metrics, analyze data and lead improvement initiatives.
  • Support risk owners in planning, execution and completion of risk assessments by providing direction, and guidance to cross functional teams.
  • Occasionally, facilitate complex or highly cross-functional risk assessments
  • Ensure product risk management documentation/files are maintained, with good documentation practices and in compliance with Warren Quality System.
  • Partner with other risk management stakeholders, including Validation, Manufacturing, Quality Control, Patient Scheduling, Facilities, Warehouse and Safety.
  • Drive continuous improvement for effective risk management and to address recurring issues identified throughout Warren.
  • Track and verify appropriate corrective actions have been implemented, documented and align with source event.
  • Maintain Warren Quality Risk Catalog, Risk Register Registry and track the status of risk mitigation actions through to completion.
  • Assist the risk owner to schedule and facilitate Warren risk assessment activities to identify risk areas and implement risk mitigation measures to support manufacturing, compliance and business continuity.
  • Conduct risk reviews and escalate findings, as appropriate, to Manager and Warren Leadership with resolution and recommendations.
  • Represent the Risk Management unit at various project meetings and provide quality input in the resolution of quality-related issues.
  • Work independently and perform with a high degree of accuracy.
  • Apply Federal (FDA) Good Manufacturing Practice (GMP) requirements, guidelines and documentation practices.
  • Proactively learn, develop and customize methods and techniques (e.g. Six Sigma/Lean, FMEA, Root Cause Analysis, etc.) to improve effectiveness of the Risk Management program.
  • Provide subject-matter expertise and consultation to risk assessment teams at the site. Develop and deliver training on QRM concepts, methods and regulatory expectations.
  • Collaborates with stakeholders to develop appropriate actions to resolve quality system issues
  • Act as primary link to other CTDO sites to ensure Quality systems are properly implemented and consistent
  • Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.
  • Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.
  • Ensure compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.
  • Review media simulation activities to ensure successful execution and documentation.
  • Ensure site is compliant with global and regulatory data governance and data integrity requirements.
  • Establishes and maintains procedures to ensure Data Integrity is maintained and procedures/processes are compliant.
  • Work with laboratory management to ensure laboratory activities comply with global regulatory requirements.
  • Ensure procedures are adequate to review and confirm appropriateness of laboratory raw data.
  • Review/approval of technology transfer related deviations/discrepancies.
  • Ensure the site stability program meets global and regulatory requirements.
  • Ensure process and method transfers, method qualifications/verifications, and analyst trainings meet company and regulatory requirements.


    • B.S. degree required.
    • Minimum of seven years of experience in the pharmaceutical or related industry.
    • Experience in CAR T or Biologics preferred.
    • Professional certification in Quality Risk Management preferred.
    • Equivalent combination of education and experience acceptable.

Keywords: Katalyst Healthcares & Life Sciences, Elizabeth , Quality - Specialist, QA Engineering, Engineering , Warren, New Jersey

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