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Job Description
- Req#: 24-129455
This position is responsible for drug delivery systems or combination product test method development and validation with minimal supervision. The candidate will develop tests including but not limited to Design Characterization and Design Verification
PRIMARY DUTIES/RESPONSIBILITIES
-Authors test methods, test protocols, test method validations, and test reports with minimal supervision
-Plans and performs experiments that support new product or technology feasibility testing.
-Conducts testing as assigned applying appropriate test methods, protocols specifications and equipment (includes product and/or equipment testing)
-Adheres to ZebraSci Quality Systems, including but not limited to; timely identification, and notification of potential Quality Events (e.g. OOS, Deviations, CAPA…) and the subsequent forward processing and investigation of such events
-Effectively communicates, orally and written, project progress and results within the Technology Development and operations team
-Responsible to maintain the lab and storage areas in a clean and organized manner.
KNOWLEDGE AND SKILLS:
-Knowledge of drug-device combination products and/or medical devices
-Knowledge of the operation of mechanical measurement equipment (e.g. Instron, Zwick), vision systems (Keyence), and container closure integrity instrumentation
-Experience with test method development and validations (MSA, Gage R&R, etc.) is desirable
-Application of statistical and analytical methods such as Design of Experiments, ANOVA analysis, and statistical software (Minitab, JMP, etc.)
-Knowledge of GLP, cGMPs, 21CFR820.30, ISO and ASTM procedures beneficial.
EDUCATION AND EXPERIENCE:
-Bachelor’s or Master’s degree in Mechanical/Biomedical/Chemical or relevant engineering field plus relevant experience related to combination product or medical device development and/or testing:
-1-5 years of experience with a BSAbout the company
Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization, and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains.
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