Biochemistry Analyst

Must Haves:Bachelor's Degree in Biology, Chemistry, Biochemistry, or other related fieldTechnical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP).Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.In depth knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.).Experience participating in the management of regulatory audits (i.e. FDA, MDSAP, ISO, OSHA, EPA, etc.)Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations.Experience with applicable instrumentation and troubleshooting. Nice To Haves:Advanced DegreeJob Description:Insight Global is seeking a Biochemistry Analyst in Durham, NC. The QC Biochemistry Analyst 2 role is responsible for routine Biochemistry testing. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry Analyst 2 will be in a key position in the Biochemistry laboratory performing testing of Description, pH, FTIR, Osmolality, Moisture Analysis, Solubility, Loss on Drying, Resin Ratio, Reflectance, and pO2 Headspace Analysis, HPLC.Responsibilities:Testing of raw materials, intermediates, special test requests, and finished product samples per standard operating procedures. Investigational writing of INVALID reports.Provide input and support for Out of Specification reports. Serve as a certified trainer for laboratory testing as applicable.

Created: 2025-06-19