Katalyst Healthcares and Life Sciences
Responsibilities:
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Work on non-conforming (NC) reports (Initiate, Analysis, Investigation, Review and close).
- Work with third party supplier to resolve issues with NC.
- Conduct Internal/Supplier Audits of the facility per ISO-1385 and/or 21CFR820.
- Develop, interpret, and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
- Conduct investigation, bounding, documentation, review, and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
- Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- Minimum required education and experience: Bachelor's degree or equivalent with 8+ years of experience, master's degree with 5+ years of experience, Doctoral degree with 3+ years of experience.
- This position will require relevant experience working in manufacturing/operations.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Experience with a proven track record of implementing appropriate risk mitigation.
- Certified Internal Audit to ISO-13485.
- Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.