Quality Engineering Specialist

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• 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.

• 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, Tap Root, 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.

Associate

Contract

Quality Assurance

Pharmaceutical Manufacturing