QC Analyst (Biochemistry)

Job description

Responsible for performing analytical testing of final product, in-process, and stability samples in a GMP-regulated biopharmaceutical laboratory. The role involves executing advanced biochemical and analytical techniques such as ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, potency assays, and Biacore, while ensuring compliance with approved SOPs and cGMP requirements. The analyst supports method transfers, method validation, equipment qualification, and troubleshooting laboratory issues to maintain operational readiness. The position also includes documenting and reviewing laboratory data, handling OOS/deviation investigations, supporting root cause analysis, and preparing technical reports. Additionally, the role involves contributing to continuous improvement initiatives, maintaining laboratory systems and documentation, and ensuring compliance with global regulatory standards including FDA, EMA, and ICH guidelines, while maintaining high standards of data integrity, safety, and quality compliance.