Associate QC Scientist

Job Summary:
The Associate QC Scientist is responsible for conducting a range of testing and operational quality control activities.

Key Responsibilities:

• Conduct various analytical, bioassay and microbiological tests, including CE-SDS, cIEF, cell-based potency assays, ELISA-based qualification, Karl Fischer titration, Total Organic Carbon (TOC) testing, UV-Vis spectrophotometry, FTIR, manual and automated titration, bioburden, sterility, container closure integrity testing (CCIT), and endotoxin testing.
• Conduct utility related sampling at utility system and environmental monitoring at manufacturing facilities.
• Assist in developing and validating analytical, bioassay and microbiological testing methods
• Assist in analyzing and interpreting analytical, bioassay and microbiological results, maintaining accurate documentation.
• Assist in investigating out-of-specification results and implementing corrective actions.
• Operate and maintain laboratory equipment and instruments.
• Manage in-process, release stability sample, and reference standards

Qualifications:

• Degree and above in pharmacy, chemistry, biochemistry, microbiology, analytical chemistry, or related field.
• Understanding of the drug development process preferred
• In-depth knowledge of cGMP and compliance principles and a strong quality-focused mindset.
• Strong attention to detail and ability to troubleshoot experimental challenges
• Ability to work independently and as part of a collaborative team
• Proficiency in English as a working language.