Quality Control Analyst II

The Siegfried Group is a global life science company with a network of 13 sites across Europe, the USA, and Asia. Siegfried offers contract development and manufacturing of active pharmaceutical ingredients, intermediates, and drug products. Siegfried employs over 3,700 people and generated sales of 1.3 billion USD in 2023. Siegfried Holding AG is listed on the SIX Swiss Exchange (SIX: SFZN). Siegfried's Acceleration Hub is the latest addition to the Siegfried network. Located in Grafton (WI), we provide comprehensive support to customers in from early phase pre-clinical and clinical development, through scale up and validation up to and including commercial manufacturing of Drug Substances. The Quality Control Analyst II is responsible for performing routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished APIs, and stability samples. Your role Conduct analytical testing on raw materials, in-process, final products, and stability samples using various laboratory equipment (e.g., pH meter, UV/Visible spectrophotometer, TOC analyzer). Perform chromatography techniques (HPLC, GC, UPLC) and a range of wet chemistry and analytical chemistry assays. Support maintenance and calibration of QC laboratory instruments; maintain lab cleanliness and readiness for audits. Review QC data, prepare summaries, and support QC Management with OOS, deviations, and CAPA investigations. Provide backup support for QC sample handling, including internal/external testing logistics and tracking. Assist in QC method development, validation, and transfer studies, as well as cleaning validation. Your profile Bachelor’s degree in Chemistry or a related field. 3-5 years of experience in the pharmaceutical industry, preferably in a cGMP or GLP environment. Technical proficiency with analytical testing, including chromatography (HPLC, GC, UPLC) and general lab equipment (e.g., spectrophotometers, TOC analyzers, pH meters). Strong knowledge of FDA GMP regulations (21 CFR, 211, 820, 600); ISO 9001 and ISO 13485 knowledge is advantageous. Advanced data analysis skills with the ability to apply statistical and mathematical methods (e.g., frequency distribution, analysis of variance, sampling theory). Proficiency in Microsoft Office Suite and laboratory software; familiarity with instrument-specific systems preferred. Exceptional organizational skills with the ability to manage multiple projects independently, meet deadlines, and work under limited supervision. Physical requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk; or sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus. Why joining Siegfried in Grafton Employee Share Program 401(k) Match Medical, Dental, and Vision (competitive cost share) Life, Sickness and Accident insurance, and Long-term disability (paid by company) Paid time off and holidays Pregnancy disability and parental leave Buy Up of Life Insurance (optional) Siegfried USA will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job.