Analyst - QC Chemistry & Device

Responsibilities Independently perform accurate and timely analytical testing of routine laboratory and stability samples per approved procedures, protocols, and GMP. Perform second person verification (SPV) and peer review of analytical data; ensure data integrity, cGMP, and site quality compliance. Record, review, and interpret analytical data in laboratory systems (e.g., LIMS) per procedures and GMP. Execute testing techniques including HPLC, UV-Vis, Capillary Electrophoresis (CE), device testing, compendial testing, and utilities testing (e.g., TOC, nitrates). Proactively identify deviations, atypical results, or out-of-trend data; initiate/support investigations. Author, review, and close analytical investigations, deviations, change controls, CAPAs, and related quality documentation. Troubleshoot analytical methods and laboratory equipment with minimal supervision. Author, revise, and review SOPs, protocols, and other controlled laboratory documents. Adhere to Environmental, Health, and Safety (EHS) standards and site policies. Contribute reliably on a small night-shift team with accountability and sound judgment. Requirements Bachelor’s degree (4-year college) in Chemistry, Biology, Microbiology, or related scientific discipline. Demonstrated experience in a GMP QC laboratory environment (routine analytical testing and data documentation). Experience working with minimal supervision in a regulated laboratory setting. Preferred (Not Required) Experience supporting manufacturing or stability testing in a regulated environment. Experience with LIMS and Empower. Hands‑on experience with HPLC, CE, device testing, and compendial methods. Experience performing SPV. Working knowledge of FDA regulations, cGMP, and compendial requirements. Experience in laboratory investigations, root cause analysis, and CAPA activities. Familiarity with Veeva Vault QMS (OneQMS) or similar systems. Strong attention to detail, communication, and organizational skills. Ability to work independently off‑shift and collaborate across shifts. Experience with lean lab and 5S concepts. Schedule / Additional Information Night shift: 10‑hour days, Sunday–Wednesday, 7:00PM–5:30AM. May require support outside the schedule for continuous (24/7) manufacturing operations. Minimal travel required. Benefits (included in posting) Anticipated pay: $65,250–$169,400. Potential company bonus for full‑time equivalent employees. Comprehensive benefits: 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance/death benefits, time off/leave, and well‑being benefits (e.g., employee assistance, fitness, employee clubs/activities). #J-18808-Ljbffr Scorpion Therapeutics