Technical Support Scientist II

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We are seeking a Technical Support Scientist II for a very important client.

Duties: Provide technical support for diagnostic products. Develop and design experiments, perform testing on Clinical Chemistry instruments, analyze data and summarize results.

Core Job Responsibilities: Conducts statistical analyses of assays, learns basic understanding of the principles of assay and instrument (hands-on knowledge and skills) and performs molecular diagnostic assays. This position is responsible for initiating and managing the change control packages for primarily for device master records and gather specific medical device attributes to support new European Union regulations. Medical device attributes: As the new European Union regulations become effective, gather attributes associated with each medical device (100 ) by evaluating product labeling, designed records and device master records per established timelines. Change control: Document types may include Manufacturing Procedures, Quality Control Procedures, Certificates of Analysis, and Material Specifications (and in some instances Labels/Package Inserts). Ensure thorough well drafted change impact assessment documents are created and assure that quality documents are properly redlined, and in- process revisions are properly controlled prior to approval. Accurately conduct a detailed review of changes for documents prior to submission to supervisor/approver(s) to ensure that all necessary documents for routing change request are in place prior to routing for approval. Ensure that documentation is appropriate, justified and approved by responsible functional areas in accordance with the timeline and in compliance to established procedures.
Requirement:
The ideal candidate will possess the following qualifications:

Experience: 2 years or advanced degree(s) may offset required years of experienceSkills: Prefer Clinical Chemistry analyzer testing experience. Knowledge of GMP, ISO and FDA regulations is desirable

Some experience in that discipline 2-4 years preferred. Familiarity with GMP and GLP and good documentation skills.
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