Quality Engineering SpecialistKatalyst Healthcares and Life Sciences • Zionsville, IN, United States
Quality Engineering Specialist
Katalyst Healthcares and Life Sciences • Zionsville, IN, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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.
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 :
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Quality Engineering • Zionsville, IN, United States
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