QC Analyst – Quality Control Chemistry

About the role

The QC Analyst provides comprehensive analytical chemistry services and technical support to the Site Quality Control laboratory. The role ensures accurate, compliant, and timely testing of raw materials, intermediates, and finished products to enable batch release and uphold the highest quality standards.

Key responsibilities

• Perform analytical techniques such as ELISA, UV/VIS spectroscopy, osmolality, oxygen headspace analysis, SDS‑PAGE, Biacore receptor binding, Karl Fischer moisture determination, and HIAC particulate analysis.
• Maintain equipment validation (IQ, OQ, PQ) and ensure methods, specifications, and SOPs meet pharmacopoeial and regulatory requirements.
• Audit daily chemistry test results, laboratory notebooks, and analytical reports for cGLP and cGMP compliance.
• Conduct Out‑of‑Specification (OOS) investigations and document findings on Certificates of Analysis.
• Collaborate with Quality Assurance, Production, Engineering, and Planning on raw material and batch release issues.
• Train junior analysts on new methods, SOPs, and best practices.
• Trend analytical results and maintain COA records.

Required profile

• Proven experience in a GMP/GLP regulated Quality Control environment.
• Strong understanding of pharmacopoeial and regulatory requirements.
• Excellent attention to detail and documentation skills.
• Effective communication and ability to work both independently and in a team.
• Proactive problem‑solving attitude.

Required skills

• ELISA
• UV/VIS spectroscopy
• Osmolality measurement
• Oxygen headspace analysis
• SDS‑PAGE
• Biacore (receptor binding)
• Karl Fischer moisture determination
• HIAC particulate analysis
• Softmax software
• Equipment qualification (IQ, OQ, PQ)
• Micro‑pipetting technique