Chemist II, Generic Analytical
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POST DATE 9/18/2016
END DATE 10/27/2016
JOB DESCRIPTIONPosition Summary:
A Chemist II must demonstrate initiative and proficient understanding of FDA regulations and working in a GMP environment. Will test raw materials and/or drug products, assist with the maintenance and calibration of analytical instruments, prepare standard and sample solutions, and maintain appropriate records. Will act as an individual contributor and work within a group setting.
Essential Duties and Responsibilities:
Prepares solutions including samples, standards, dissolution media, buffers, mobile phases and diluents following controlled procedures (test method or validation protocol) and documenting the tasks in a laboratory notebook. Must comply with regualtory, GxP requirements and company procedures, while remaining orgainzed, accurate and properly budgeting the use of time.
Operates a variety of analytical instruments or equipment (e.g. GC, IC, CE, HPLC, UV, dissolution tester, FT-IR, pH meter, etc.) to prepare or analyze samples and standards and/or perform other wet chemistry techniques.
Train other Chemists on laboratory techniques.
Support validation of Assay and Dissolution methods and testing of cleaning verification samples.
Support the instrumentation specialists with regular maintenance of laboratory instruments
Support other projects as directed that lead to clinical studies and/or to the filing of ANDA s.
Other tasks as needed in the R&D Lab.