Position Summary:
Advanced Quality Technician Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes. Ensure compliance with world wide regulatory expectations/requirements.
Key Responsibilities:
- 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.
- 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.
- 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.
- Provide compliant solutions to a variety of problems of moderate scope and complexity.
- Responsible for demonstration of core competencies.
- Holds certification in at least one technology or test process within the area.
- 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.
Required Education & Experience:
- Demonstrates proven track record utilizing core & technical competencies.
- Bachelor’s degree or equivalent* experience is required, typically in life sciences or engineering.
- Demonstrates understanding of how their function supports the business.
- Proficient in lab techniques, including but not limited to wet chemistry, pipetting, qualitative and quantitative transferring. Operational/quality knowledge.
- Must have understanding of core competencies. Proficient level of technical competencies.
- (Associates Degree with 4 years related experience, or High School diploma plus 6 years of related experience ) years’ experience Quality or related field-minimum of 1-2 years’ experience Industry- minimum 3 year.
- Less experience may be appropriate with advanced degree.
- Preferred Healthcare industry and experience in quality function.
- Highly desirable experience includes: Molecular biology techniques, including PCR and FISH.
- Performing Out of Specification (OOS) investigations. MQA and or nonconformance/CAPA work experience