<p>The Position</p> <p>This position is within the Quality Control structure, under the Quality Organization. An Associate Scientist III, 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 III 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>2nd shift work hours are ~1pm - 11:30pm and includes a shift differential.</p> <p>Responsibilities</p> <p>responsibilities to this position:</p> <ul> <li>Developing understanding and 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>Proficient 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 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>Drafts technical documents such as OOS/atypical investigations, deviations and CAPAs </li><li>Demonstrates good written and verbal communication skills </li><li>Proficient in analyzing 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>Establishing attention to detail </li><li>Calibration, maintenance, and troubleshooting of analytical equipment with limited supervision. </li><li>Remains flexible with changing priorities </li></ul> <p>Requirements:</p> <ul> <li>BS. in Chemistry with 5 years of relevant laboratory experience </li><li>Knowledgeable of cGMP laboratory requirements and operations </li><li>Familiar with analytical instrumentation, test methodology/validations, data acquisition systems, and typical cGMP policies and practices. </li></ul>