QC Lead
Vor 5 Tagen
We are seeking a highly skilled Senior QC Analyst to join our client's Quality Control team on a 12-month contractual basis, specializing in raw material testing and spectrometry.
The successful candidate will be responsible for performing analytical testing on raw materials using spectroscopic techniques such as FTIR, UV-Vis, and ICP-MS/AES, ensuring compliance with regulatory standards (e.g., USP, EP, GMP).
Key Accountabilities:- Develop, validate, and troubleshoot spectrometry-based assays.
- Conduct qualitative and quantitative analysis of raw materials using spectroscopic and chromatographic techniques.
- Review and interpret analytical data, ensuring accuracy and compliance with cGMP, FDA, and ICH guidelines.
- Investigate OOS (Out of Specification) and OOT (Out of Trend) results, implementing corrective actions.
- Collaborate with cross-functional teams to support supplier qualification and raw material release.
- Maintain and calibrate analytical instruments to ensure optimal performance.
- Document results in LIMS, laboratory notebooks, and regulatory reports.
To be successful in this role, you will require:
- Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related field.
- 5+ years of QC experience in a pharmaceutical, biotech, or chemical manufacturing environment.
- Proficiency in FTIR, UV-Vis, ICP-MS, and other spectroscopic techniques.
- Strong knowledge of GMP, USP, EP, and regulatory compliance.
- Experience with LIMS and electronic data management systems.
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