Senior QC Analyst
Vor 4 Tagen
We are currently looking for an experienced Senior QC Analyst to join our dynamic client team a leading CDMO. In this role, you will perform a wide variety of chemical and biological analyses, ensuring the highest quality standards in support of quality assurance and control programs.
Key Responsibilities:
- Perform analytical testing (HPLC, UPLC, GC, UV/VIS, IR, and more) on raw materials, products, and samples.
- Review analytical data and write/review GMP documents (test methods, SOPs, validation reports).
- Handle deviations, OOS, and change controls.
- Support internal and external audits, ensuring compliance with regulations.
- Lead method transfers, validations, and new equipment commissioning.
- Contribute to cross-functional projects and provide QC team support.
- Implement Lean methodologies to drive efficiency and productivity improvements in QC.
Qualifications:
- BS/BA in Life Sciences or related field.
- Minimum of seven years of experience in multifunction testing in the following QC testing sectors: Chemistry, AS&T, Microbiology, or Stability.
- Deep working knowledge of HPLC/UPLC in a regulated environment.
- Experience with SE-UPLC, peptide, and glycan assays is desirable.
- Solid understanding of Lean project management, planning, and reporting tools.
- Knowledge of Veeva Vault, Trackwise, LIMS, and MS Office applications.
- Fluent in English (C1), French is a plus.
- Empower required.
For further information about this position, please apply with your CV.
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