Quality Engineering Specialist

1 week ago

Indianapolis, Indiana, United States Katalyst CRO Full time $80,000 - $120,000 per year

Responsibilities

  • Lead and manage reliability improvement projects within operations and engineering.
  • Author 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.
  • Act 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.
  • Analyze 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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