QC Scientist II – Data Review Position Available In St. Louis, Missouri

Job Title:

QC Scientist II – Data Review Job Description As a QC Scientist II, you will perform crucial work that makes a tangible impact on the world. Your contributions will aid in discovering cancer cures, safeguarding the environment, and ensuring safety. You will be supported in reaching your career objectives and be part of a culture that encourages continual growth and learning. Responsibilities Create QC Raw Materials (QCRM) specification documents in accordance with internal SOPs and external regulations. Review batch records, process validation protocols/reports, technical transfer documents, and product specifications with high attention to detail. Assess the impact of changes on the testing laboratory. Collaborate with QCM laboratory scientists to support laboratory needs and questions. Review bioburden and endotoxin Raw Data for the QC Microbiology (QCM) laboratory. Generate Certificates of Testing for bioburden and endotoxin results. Support QCM testing by providing matrices, SOPs, and other testing protocols. Essential Skills Minimum of 1-2 years of USP Microbiology experience in the quality/pharmaceutical industry. Knowledge of GMP regulations in cGMP manufacturing environment. Working knowledge of scientific principles for a wide range of compendia techniques. Experience in quality control, analytical chemistry, and wet chemistry. Proficient in Microsoft Office (Word and Excel). Additional Skills & Qualifications Experience with raw material compendia testing is a plus. BS/BA in biology, biochemistry, chemistry, or a related science field OR equivalent industry experience. Experience with bioburden and/or endotoxin assays. Knowledge of international health authority guidelines. Experience with Smartsheet and Trackwise systems is desired. Work Environment This role is a Monday-Friday position, from 8:00am to 4:30pm, with a flexible start time post-training to cover core hours between 9am and 3pm. Once fully trained, one work from home day will be offered. The position involves desk work with 10% standing/walking and 90% sitting at the desk/office. Personal Protective Equipment (PPE) such as lab coats, gloves, eye protection, and safety shoes are required. The environment may involve exposure to fumes, chemicals, acids, and bases.