QC 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.

Working at Siegfried

Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.

Who we are

In the Midst of People’s Lives – Across the Globe

The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model.

The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production.

We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.

What we do in Grafton

The Siegfried Acceleration Hub in Grafton specializes in early-phase development and manufacturing services, including services for projects with highly potent APIs.

Competencies

· Early-phase development and manufacturing

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General Information