Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
Quality Technician Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes. Ensure compliance with world wide regulatory expectations/requirements.
- Responsible for carrying out tasks related to core job responsibilities with management oversight.
- May lead a goal with a limited scope, but usually a contributor on broader goals.
- Provide compliant solutions to a variety of problems of moderate scope and complexity.
- Responsible for demonstration of core competencies.
- Expected to elevate any issues to management, as necessary, in meeting these responsibilities.
- Performs Quality Control test procedures, evaluates quantitative and qualitative test results, provides secondary review of test data, troubleshoots instrumentation, dispositions test results for molecular diagnostic assays and intermediate manufactured parts.
- Dispositions incoming material for use in manufacturing and/or manufactured material for product for sale.
- Generates exception/CAPA documentation such as non-conformance reports and investigation reports required at the site for routine and non-routine nonconformances.
- Independently evaluates all aspects of the exception event product impact; risk impact; corrections, and if CAPA is required.
- Responsible for materials segregation activities.
- Generate, review and approve Certificate of Assurance for manufactured and tested products.Holds certification in at least one technology or test process within the area.
- Bachelor’s degree or equivalent* experience is required; typically in life sciences or engineering. *(Associates Degree with 4 years related experience, or High School diploma plus 6 years of related experience )
- Minimum 3 years experience.
- Preferred Healthcare industry and experience in quality function.
- Demonstrates understanding of how their function supports the business.
- Demonstrates proven track record utilizing core & technical competencies.
- Must have understanding of core competencies.
- Proficient level of technical competencies.
- Required experience includes; Proficient in lab techniques, including but not limited to wet chemistry, pipeting, qualitative and quantitative transferring.
- Operational/quality knowledge.
- Highly desirable experience includes: Molecular biology techniques, including PCR and FISH. Performing Out of Specification (OOS) investigations.
- MQA and or nonconformance/CAPA work experience.