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Specialist, QA Engineering

Specialist, QA Engineering

TSRSummit, NJ
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Summary

2. REQUIRED COMPETENCIES : Knowledge, Skills, and Abilities

  • Must have GMP, Quality, and in-depth risk management knowledge.
  • Must be able to recognize and group technical / scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.
  • Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
  • Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
  • Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.
  • Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.
  • Must provide guidance to other employees in the interpretation of technical / scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
  • Routinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.
  • Able to fully interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
  • Effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams.
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
  • Consults management for advice on complex issues.
  • Work is self-directed.
  • Is recognized Subject Matter Expert within the group.
  • Able to prepare written communications and communicate problems to management with clarity and accuracy.
  • Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
  • Understands fundamental scientific problems.
  • Able to write and review reports with clarity and brevity.
  • Able to produce data reports with precision.

3. DUTIES AND 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.

    • 4. EDUCATION AND EXPERIENCE (As Applicable)

  • 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.
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