Job Description
We are seeking a highly skilled and detail-oriented Quality Control Specialist to join our Biologics Division.
The successful candidate will have extensive experience in analytical techniques, including HPLC, GC, MS, and wet chemistry. Strong knowledge of GMP regulations and compliance is essential.
* Perform analytical tests using various techniques, including HPLC, Capillary Electrophoresis, UV-Vis spectroscopy, Ion Chromatography, GC, and wet chemistry.
* Troubleshoot and resolve issues related to analytical methods and equipment.
* Develop, verify, and validate analytical methods using equipment such as HPLC, Ion and Gas Chromatography, spectrophotometers, and wet chemistry techniques.
* Process and analyze test samples using LIMS software.
* Safely dispose of laboratory waste.
* Conduct data calculations and statistical analysis.
* Participate in internal, regulatory, and client audits and respond to findings.
Requirements
* Bachelor's or Master's degree in a relevant science discipline (e.g., chemistry, biochemistry, pharmacy, biotechnology).
* A minimum of 3 years' experience in a laboratory setting, preferably within a GMP-regulated environment (EMEA/FDA) within the pharmaceutical, medical device, CRO, CMO, or CDMO industry.
* Strong background in analytical techniques, including HPLC, GC, MS, and similar methodologies.
* Experience in developing and validating analytical methods according to ICH guidelines is desirable but not essential.
* Proficiency in immunoassays is a plus but not required.