Quality Control Analyst

Job TitleQC Biochemistry Analyst 2Hire Type6+ Month ContractSummaryWe are seeking a QC Biochemistry Analyst 2 to join our fast-paced, FDA-regulated Medical Devices/Diagnostics laboratory. This role is responsible for performing testing on raw materials, intermediates, and finished products, maintaining compliance with SOPs, GLP, GMP, and HSE requirements, and supporting laboratory investigations and audits. The analyst will serve as a certified trainer, provide input on Out of Specification reports, document test results in LIMS, and assist with continuous improvement initiatives. Key laboratory testing includes pH, FTIR, osmolality, moisture analysis, solubility, HPLC, and other biochemistry analyses.Key ResponsibilitiesConduct QC testing and document results accurately and timely.Lead as a trainer for laboratory testing and instrument maintenance.Troubleshoot laboratory equipment issues and support validation protocols.Maintain compliance with regulatory, safety, and quality standards.Support investigations, Out of Specification reports, and audit preparation.Participate in continuous improvement and 6S initiatives.QualificationsBS with minimum 2 years of experience, or a Master's degree or PhD with 0 years of experience, in a regulated laboratory environment, Chemistry or Biochemistry is highly preferred.Technical 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.Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.

Created: 2025-10-02