In this role, you will collects environmental monitoring samples including high quality water systems, cleanroom environments and gases in the field (manufacturing, utilities and laboratory locations).
The Quality Engineer will work closely with internal process owners to establish, document, monitor, evaluate, maintain and improve company's QMS in accordance with AS9100, customer and regulatory requirements.
In this role, the selected candidate will perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.
The Chemist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products using HPLC, GC, Dissolution, AA, UV-Vis, Wet Chemical Analysis and Method Development.
Performs professional Quality Engineering assignments of considerable complexity under limited direction supervision ie. Conducts statistical analysis in the form of capability studies, DOEs, etc to evaluate processes.
Analyze statistical data to evaluate trends and investigate failures completely to determine the root cause.Take appropriate company or vendor corrective action to revise design, methods or inspection/test instructions to prevent failure recurrence.
In this role, the selected candidate must have a hands-on, automation experience, be able to help drive QC processes across the organization (code reviews, root cause analysis, collecting and analysis of statistics, etc.).
This position will perform and deliver on routine assignments and projects for his/her assigned area(s) of responsibility. S/he is responsible for documenting procedures; conducting quality audits of transactions and/or monitoring calls for internal and/or outsourced services/processes.
This is a true hands-on manual testing role, must be very comfortable in a roll up your sleeves environment; experience in a formal SDLC background with Hewlett Packard Application Lifecycle Management tools is preferred.