Quality Control Chemist I

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the world. Why KindevaPurpose-driven work environmentSignificant growth potentialCollaborative team cultureDirect impact on patient careIndustry-leading innovationThe Impact You Will Make:Transform Lives Through Innovation Join a rapidly expanding pharmaceutical CDMO where your work directly impacts patient health outcomes worldwide. Kindeva offers a rewarding and fast-paced cGMP pharmaceutical environment where your work directly contributes to the safety quality and efficacy of life-saving drug a Chemist I you will perform routine and non-routine quality control testing of raw materials in-process materials finished products and stability samples contribute to investigations and continuous improvement initiatives and develop your analytical skills alongside a dedicated and collaborative Opportunity:Our St. Louis facility continues to grow creating exciting opportunities for professional development and career advancement. Join us during this dynamic phase of growth and expand your expertise in analytical chemistry GMP laboratory operations investigation support and pharmaceutical quality systems while contributing to life-saving healthcare :Laboratory Operations & TestingPerform and coordinate routine setup calibration operation and maintenance of laboratory instruments and samples using a variety of analytical techniques and instrumentation in accordance with established procedures and or coordinate testing schedules to support business priorities and timely completion of laboratory Operations & TestingPerform routine setup calibration operation and maintenance of laboratory instruments and samples in accordance with established departmental site and corporate procedures specifications and solutions and standardize test solutions as defined by analytical methods or compendial assigned work in a timely and safe manner while complying with regulatory company and compendial cGMP principles including proper laboratory documentation maintenance of records archival of raw data attention to specification limits and immediate notification of any out-of-specification (OOS) and record analytical testing activities and data ensuring reports are accurate complete and traceable to procedures equipment instruments and reagents practical laboratory skills and a strong understanding of chemistry theories analytical techniques and quality and revise SOPs analytical methods and related laboratory documentation as Technology & Continuous ImprovementParticipate in routine calibration verification and maintenance activities for laboratory propose and implement process and method improvements that enhance efficiency robustness compliance and data data collection trend analysis and peer review activities associated with process improvement Collaboration & DocumentationCollaborate closely with Manufacturing Quality Assurance Validation Technical Services and Process Transfer teams to address technical and operational compliance with Good Documentation Practices (GDP) data integrity requirements and cGMP :Knowledge of compendial requirements including USP EP and other applicable references; cGMP guidelines; FDA regulations; laboratory safety procedures; SDS requirements; laboratory instrumentation; and inorganic and organic chemistry Degree in Chemistry Biochemistry Pharmaceutical Sciences or a related scientific discipline with 03 years of laboratory experience or an equivalent combination of education and experience/training. Experience in a GMP-regulated pharmaceutical biotechnology medical device or other regulated laboratory environment is to read and interpret compendial methods SOPs technical procedures scientific literature professional journals and governmental regulations. Ability to author scientific reports business correspondence and departmental procedures Ability to perform mathematical calculations using whole numbers fractions decimals and basic statistical functions including graphing and interpretation of to define problems collect and analyze data establish facts and draw valid with analytical instrumentation and laboratory techniques such as HPLC UPLC GC Dissolution UV/Vis FTIR Karl Fischer particle size analysis or similar technologies is of Windows-based software applications such as Word Excel and Outlook; experience with chromatography data systems and data processing software particularly Empower is have the ability to multitask across multiple priorities and responsibilities while maintaining attention to detail and compliance have the ability to work effectively under strict production quality and performance deadlines. Must be willing and able to support business needs outside of standard work hours when required including occasional evenings weekends and with SDS-PAGE Western Blot icIEF Plate Reader ELISA and large molecule testing is graduates with relevant internship co-op undergraduate research or academic laboratory experience are encouraged to Demands/Qualifications:Employee is required to regularly use hands in order to handle materials and suppliesEmployee is required to use computers for an extended period each dayEmployee is required to effectively use electronic communicationEmployee is required to regularly stand and walk for extended periods of timeEmployee must occasionally lift and/or move up to 20 poundsAbility to use proper PPE and be conscious of the work area hazardsEmployee is required to follow all site safety proceduresJoin our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.# LI-Onsite