Lavori attuali relativi a Quality Control Analyst - Monza, Lombardia - Thermo Fisher Scientific
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Quality Control Specialist
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Quality Control Specialist
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Quality Control Specialist Cosmetici
1 mese fa
Monza, Lombardia, Italia Page Personnel A tempo pienoDescrizione del LavoroIl Quality Control Specialist Prodotti Cosmetici risponde al responsabile di funzione e ha l'obiettivo di controllare tutti i prodotti prima dell'invio al cliente. Le attività principali includono:Controllo visivo del prodotto finitoControllo visivo e dimensionale del packaging (primario)Controllo di processo visivo e...
Quality Control Analyst
3 mesi fa
At Thermo Fisher Scientific, you will engage in impactful work and collaborate with a team that prioritizes excellence, innovation, and quality. As a vital part of a thriving global enterprise, you will be empowered to reach your full potential. With over $35 billion in revenue and the highest investment in research and development in the industry, we provide our employees with the tools and opportunities to make significant contributions to society.
The Monza facility ensures compliance with controlled substance regulations across Europe and offers advanced 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, encompassing all major international markets, including Europe and Asia Pacific.
The selected candidate will become a member 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 the analysis of both small and large molecules, including HPLC, GC, IR, UV-Spectrophotometer, and other essential equipment. Your work will support product development initiatives (covering both API and Drug Product) as well as stability testing and other tasks as requested by clients. Experience in a cGMP environment is essential for this role, and familiarity with Empower software is required. Proficiency in MS Office is also necessary.
Main Responsibilities:
- Conduct testing of raw materials (particularly APIs), in-process and finished products, and formulations in accordance with Standard Operating Procedures (SOPs).
- Perform Analytical Method Development, Analytical Method Transfer, and Validation, along with routine and stability analyses. Compile data for documentation of testing procedures and prepare reports. Ensure that 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:
- Required: 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 necessary 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 Good Manufacturing Practices (GMP).
- 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
Personal Attributes:
- Flexibility
- Strong organizational and planning skills
- Ability to work collaboratively within a team
