Quality Control Analyst

1 settimana fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

At Thermo Fisher Scientific, you will engage in innovative work and collaborate with a team that prioritizes excellence, quality, and creativity. As a member of a thriving global organization, you will be empowered to excel in your role. With revenues exceeding $35 billion and the highest investment in research and development in the industry, we provide our employees with the resources and opportunities to make significant contributions to the world.

The Monza facility ensures compliance with controlled substance regulations across Europe and offers cutting-edge disposable manufacturing technologies alongside fully integrated secondary packaging services. It has garnered regulatory approval from various international inspection agencies, including ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, and Turkey. The Monza site currently serves over 20 countries, covering all major international markets, including Europe and Asia Pacific.

The selected candidate will become part of the Analytical Development & GMP Department within the newly established Pharmaceutical Department (PDS).

In this position, you will utilize a variety of analytical instruments for both small and large molecule analysis, including HPLC, GC, IR, UV-Spectrophotometer, and other minor equipment. Your work will support product development initiatives (both API and Drug Product), stability testing, and other client-requested tasks. Experience in a cGMP environment is essential, and familiarity with Empower software is preferred. Proficiency in MS Office is also required.

Main Responsibilities:

  • Conduct testing of raw materials (particularly APIs), in-process and finished products, and formulations in accordance with SOPs.
  • Perform Analytical Method Development, Analytical Method Transfer and Validation, as well as routine and stability analysis. Compile data for documentation of test procedures and prepare reports. Ensure all testing processes, monitoring, and departmental documentation comply with SOPs and cGMP regulatory standards.
  • Contribute to the development of new concepts, techniques, and standards. Assist in the preparation of Certificates of Analysis (CoAs).

Qualifications:

  • Bachelor's degree in chemical pharmaceutical, biology, chemistry, biotechnology, or a related field, or equivalent work experience and knowledge.
  • Proficiency in office software.
  • Comprehensive understanding of common analytical techniques and required instrumentation (HPLC, FT-IR, UV-VIS, physical tests, etc.).
  • Experience with stability and routine testing on APIs and finished products.
  • Familiarity with company procedures and GMP regulations.
  • Knowledge of laboratory computer programs.
  • BS required; MS preferred in a science-related field with 1-2 years of laboratory experience, ideally in a pharmaceutical, biotechnology, healthcare, research, or academic setting.

Languages:

  • English

Desired Attributes:

  • Flexibility
  • Strong organizational and planning skills
  • Ability to work collaboratively in a team environment

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