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Quality Engineering Specialist
Quality Engineering SpecialistKatalyst Healthcares and Life Sciences • Zionsville, IN, United States
Quality Engineering Specialist

Quality Engineering Specialist

Katalyst Healthcares and Life Sciences • Zionsville, IN, United States
[job_card.variable_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

Responsibilities :

  • Lead and manage reliability improvement projects within operations and engineering.
  • uthor and review Change Control and Quality documents related to product or process modifications.
  • Maintain operational compliance with US and international regulatory standards (FDA, EU, HC, TGA, PIC / S, ISO, USP, NRC, cGMP, etc.).
  • Review and support validation activities (equipment, cleaning, and process).
  • Prepare for and participate in regulatory and internal audits.
  • ct as the QA contact for risk management activities, including FMEAs.
  • Investigate deviations, OOS results, and customer complaints, ensuring timely closure with appropriate corrective and preventive actions.
  • nalyze and report batch data to identify trends and compliance risks.
  • Develop, review, and revise SOPs, Batch Records, and training documentation with proper change control.
  • Collaborate cross-functionally to drive problem-solving and continuous improvement across operations.

Requirements :

  • Bachelor's degree in Life Sciences or Engineering (required).
  • 2+ years of relevant experience, preferably in a pharmaceutical or aseptic manufacturing environment.
  • Strong understanding of cGMPs and regulatory compliance.
  • Demonstrated expertise in root cause analysis tools (e.g., 5 Whys, Fishbone / 6M, TapRoot, Kepner-Tregoe).
  • Experience with statistical analysis tools; certification in Lean or Six Sigma preferred.
  • Strong project management, organizational, and communication skills.
  • Proficiency with Microsoft Office Suite, MS Project, and Visio.
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    Quality Engineering • Zionsville, IN, United States

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