QUALITY ANALYST (IN VITRO DIAGNOSTICS) Micronics
THIS JOB HAS EXPIRED The successful candidate will define, document, analyze, perform, and interpret diagnostic
assays for new and/or modified products, product components (e.g., reagents, materials) and
production processes; investigate product related assay problems to determine root cause and
collaborate with other personnel to develop and implement solutions.
SCOPE AND RESPONSIBILITIES
? Provides hands on development and optimization of molecular biology and immuno-
? Assists in the qualification and validation of Quality Control methods for assays and their
integration into diagnostic devices;
? Writes assay and diagnostic system standard operating procedures (SOPs);
? Develops and performs Quality Control tests;
? Develops and performs other Method Development / Quality Control duties as required;
? Reviews new and existing physical, chemical and biological test methods to determine
appropriateness (accuracy and precision) for company use.
? Reviews requirements of published standards and regulations to determine company
compliance and/or recommend required actions.
? Supports verification and validation (product and processes) testing of new products and
design changes to existing product.
? Minimum 5 years lab experience in molecular diagnostic and immunoassay
development with SOP development experience.
? Strong attention to details; solid math and analytical skills
? Highly self motivated
? Fluent in Microsoft Word and Excel
? Works well in multi-disciplinary team environment; able to manage time and
deliverables on schedule.
? Bachelors Degree in Life Sciences discipline with 8 years experience or Masters
Degree and 5 years experience.
||8463 154th Avenue, Northeast |
Redmond, WA 98052
THIS JOB HAS EXPIRED