Quality - Specialist, QA Engineering

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

Job Description:

Responsibilities:

• 
  
• 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.
  
  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