Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summary: \n\nProvide analytical support in the Laboratory Operations Department by following standard practices. Perform analytical testing as assigned for on prototype, CTM (Clinical Trial Material) and Commercial batches supporting development and/or manufacturing operations. Make detailed observations and reviews, documents, and communicates test results. \n\n \n\nEssential Functions: \n\nDocument all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA). \n\nCarry out independently HPLC, dissolution and physical testing analysis testing following established procedures Analytical Methods & Standard Operating Procedures (SOPs). \n\nWork Proficiency with Empower, NuGenesis, MS Word & Excel Software. \n\nPerform basic troubleshooting to overcome system suitability failures. \n\nRecognize and report unexpected or Out Of Specification (OOS) results immediately to the Supervisor and conducts laboratory investigations under direction. \n\nMaintain a safe working environment and report potential hazards. \n\nMay be essential to perform alternating or rotating shift work (as required) \n\n \n\nREQUIRED QUALIFICATIONS \n\n \n\nEducation: \n\nHigh school diploma/General Educational Development (GED) Certificate is required \n\nWorking towards B.Sc. in chemistry \n\n \n\nExperience: \n\nPrevious experience in a science related environment. \n\n \n\nEquivalency: \n\nEquivalent combinations of education, training, and relevant work experience may be considered. \n\n \n\nKnowledge, Skills and Abilities: \n\nGood understanding of basic chemistry and experience with common laboratory equipment and operation. Good understanding of chromatographic seperations. Knowledge of qualitative and quantitative chemical or microbiological analysis. Awareness of quality and regulatory requirements in the pharmaceutical industry. Good problem-solving skills and logical approach to solving scientific problems. Demonstrable interpersonal and communication skills (both oral and written). Ability to read and interpret technical procedures and governmental regulations. Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques. Proficiency with the English language. Works well independently and in a team environment.