What are the responsibilities and job description for the Quality Engineering Specialist position at Katalyst CRO?
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.
- 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.