Quality Engineering Specialist

Katalyst Healthcares and Life Sciences

Zionsville, IN

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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Vacancy posted 5 days ago

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