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Quality Control Scientist

Salary undisclosed

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QC Scientist - Micro, Raw Material

Job Summary:

The QC Scientist (Micro + RM) is responsible for a range of testing and quality assurance activities. This role requires experience in raw material testing, in-process control (IPC), environmental monitoring, water testing, and finished product testing. The candidate should be proficient in HPLC and GC operations, including troubleshooting.

Key Responsibilities:

  • Conduct various analytical 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.
  • Develop and validate microbiological testing methods in line with regulatory guidelines.
  • Analyze and interpret microbiological results, maintaining accurate documentation.
  • Assist in investigating out-of-specification results and implementing corrective actions.

Qualifications:

  • Bachelor’s degree or higher in pharmacy, chemistry, biochemistry, analytical chemistry, or related fields, with a minimum of 2 years of experience in biotech or biopharma.
  • Strong understanding of the drug development process.
  • In-depth knowledge of cGMP compliance principles and a strong quality-focused mindset.
  • Familiarity with FDA, EMA, NMPA, ICH, WHO technical guidelines, as well as USP, Eur.P, and ChP pharmacopeias.
  • Extensive experience with IND/IMPD, NDA, and ANDA submissions.
  • Proficiency in English as a working language.