<p>The Position</p> <p>This position is within the Quality Control structure under the Quality Department. An Associate Scientist I, Quality Control will support the analytical testing of pharmaceutical raw materials, in-process samples, finished drug substances and drug product, and/or stability sample testing activities for new drug substances and drug products. The Associate Scientist I will also support testing required for GLP Toxicology and cGMP Clinical Trial material release, as well as stability studies. The Associate Scientist I is expected to perform several analytical techniques and can make sound scientific decisions under guidance from management. This position reports to QC Laboratory Management.</p> <p>Responsibilities</p> <ul> <li>Developing knowledge of cGMP requirements </li><li>With guidance from laboratory leadership, works to meet project timelines and deliverables </li><li>Performs routine analytical testing of pharmaceutical raw materials, in-process samples, finished products and/or stability samples using established test methods and procedures </li><li>Executes training requirements, applies relevant SOPs and associated procedural guides </li><li>Ensures that training records are up to date and in compliance </li><li>Familiar with various analytical instrumentation theory and practice </li><li>Trains on, and becomes proficient with, a variety of analytical instrumentation (e.g., HPLC, GC, FT-IR, UV/Vis, KF, etc.) </li><li>Can set up various instrumentation for testing according to written test methods with little to no supervision </li><li>Plans and executes work related tasks with minimal supervision </li><li>Performs analyses in a timely manner </li><li>Works collaboratively with others </li><li>Shows initiative and interest in learning new techniques and tests </li><li>Identifies and troubleshoots minor analytical problems with instrumentation, general chemistry and computer applications </li><li>Quickly communicates analytical or sample issues to senior staff and/or management </li><li>Maintains a clear, concise and accurate laboratory notebook or worksheet records. </li><li>Reviews test data acquired by others, as applicable. </li><li>Aids with the drafting of technical documents such as OOS/atypical investigations, deviations and CAPAs </li><li>Possesses good written and verbal communication skills </li><li>Consistently and correctly analyze data/results and interpret outcome of experiments and to propose appropriate follow-up with supervision. </li><li>Embraces cGMP requirements for all associated work </li><li>Works cooperatively in a team environment </li><li>Developing attention to detail </li><li>Calibration, maintenance, and troubleshooting of analytical equipment with supervision. </li><li>Remains flexible with changing priorities </li></ul> <p>Requirements:</p> <ul> <li>B.S. in Chemistry (or related field) with 1-3 years of relevant laboratory experience </li><li>Experience with cGMP laboratory requirements and operations </li><li>Familiar with analytical instrumentation, test methodology/validations, data acquisition systems, and cGMP policies and practices </li></ul>