Quality - Specialist, QA Engineering
Company: Katalyst Healthcares & Life Sciences
Posted on: May 17, 2023
- 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
- 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
- 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
- Occasionally, facilitate complex or highly cross-functional
- 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
- 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
- Conduct risk reviews and escalate findings, as appropriate, to
Manager and Warren Leadership with resolution and
- Represent the Risk Management unit at various project meetings
and provide quality input in the resolution of quality-related
- Work independently and perform with a high degree of
- 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
- 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
- Ensure the site stability program meets global and regulatory
- 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
- Experience in CAR T or Biologics preferred.
- Professional certification in Quality Risk Management
- Equivalent combination of education and experience
Keywords: Katalyst Healthcares & Life Sciences, Elizabeth , Quality - Specialist, QA Engineering, Engineering , Warren, New Jersey
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