Research Associate II, Quality Control

Position Summary As a Research Associate II, execute routine Quality Control (QC) testing activities as assigned. Support CAPAs, change controls, investigations, and deviations; participate in development and validation of analytical methods for the Analytical Development group. Assist with testing, project support, data review, ordering laboratory supplies, and laboratory upkeep. Principal Duties and Responsibilities Support QC analytical chemistry testing using HPLC, UPLC, GC, KF, dissolution, and other instrumentation. Author technical reports as required. Ensure instrument calibration and qualification are up to date. Troubleshoot instrumentation issues and coordinate vendor repairs. Coordinate with Supervisor on scheduling testing for reagents and product samples. Participate in data review. Participate in method development and validation. Coordinate external outsourcing of testing. Support CAPAs, change controls, investigations, and deviations; ensure timely closure with Quality Assurance. Follow Good Documentation Practices (GDP) and maintain contemporaneous records/logbooks/forms. Adhere to cGMPs at all times. Requirements Bachelor’s degree in Chemistry or related field. 2+ years of experience in a GMP Quality Control environment. Prior experience with HPLC and UPLC. Preferred Knowledge of CFR 210, 211, USP, and FDA/ICH guidance. Experience with USP App IV dissolution apparatus. Skills/Knowledge Knowledge of safe laboratory practices. Strong verbal and written communication. Working Conditions Mix of office and laboratory environments; must be able to work in chemical laboratory environments. #J-18808-Ljbffr Scorpion Therapeutics