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Work Performed:
Duties include but are not limited to:
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Independently conduct analytical research and develop methods to test pharmaceutical
products for conformance to established specifications.
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Conduct method validation and transfer.
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Responsible for developing and executing analytical protocols (e.g. Method validation)
and draft related testing methods and validation reports. |
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Develop test method for evaluating both the physical and chemical aspects of new
pharmaceutical products. |
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Conduct analytical investigations to support formulation, quality control and product
related troubleshooting. |
Aspects of Performance:
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Maintains confidentiality. |
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Possesses sound documentation skills. |
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Demonstrates ability to prioritize conflicting demands. |
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Executes assigned tasks within established schedule. |
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Writes and speaks clearly and concisely. |
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Develop & maintain expertise through continuing education & training. |
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Comply with Company policies, procedures, rules and regulations. |
Qualifications:
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Competency with Microsoft Office Suite. |
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Strong organizational skills, attention to detail and
ability to multi-task. |
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Must understand GMP regulations. |
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Must be familiar with ICH and FDA guidelines. |
Education:
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Bachelor's Degree, Master's Degree or Ph.D. in Chemistry. |
Experience:
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Two years of pharmaceutical working experience is required with a Ph.D.. |
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Five years of pharmaceutical working experience is required with a Master's degree. |
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Ten years of pharmaceutical working experience is required with a Bachelor's degree. |
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Must have HPLC, GC, Dissolution, UV/VIS, IR, LC/MS experience. |
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GC/MS experience is a plus. |
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