Senior/ Analyst QC (Biochemistry)

What you'll do:

• Execute and interpret analytical techniques, including ELISA, PCR, CE, SDS-PAGE, IEF/icIEF, HPLC, spectroscopy, potency, and other methods.
• Test final product, in-process, and stability samples per SOPs, ensuring compliance with cGMP and data integrity standards.
• Document and review laboratory results support OOS and deviation investigations with report drafting.
• Troubleshoot methods and equipment participate in validation, qualification, and method transfer activities.
• Prepare and maintain standards, reagents, and lab inventory in accordance with GMP requirements.
• Train and mentor team members on test methods and lab procedures.
• Lead projects, manage multiple priorities, and support continuous improvement initiatives.
• Engage with customers and regulatory agencies during audits, inspections, and technical discussions.

What we're looking for:

• Degree or higher with 8 years of QC/Quality experience in biopharmaceuticals
• Preferably lab experience in biotech or medically related fields
• Familiarity with FDA, EMEA, ICH guidelines and GMP quality systems
• Strong planning, prioritization, and documentation skills
• Good communication and interpersonal abilities
• Analytical, meticulous, and quality-focused mindset
• Team player who can work independently with strong safety and timeline discipline
• Openness to new challenges and continuous improvement