Quality Control Chemist I

Biotech QA/QC AnalystYou will join a biotech QA/QC function focused on analytical testing of materials and products to support release and regulatory compliance. In this role you ensure accurate test data, maintain lab instruments, and help investigate deviations and OOS results. You collaborate with cross-functional teams to uphold GMP and quality standards while contributing to continuous improvement. This position offers hands-on experience with biopharmaceutical analytical methods and exposure to regulatory environments.ResponsibilitiesTest raw materials, intermediates, and final products using cell-based bioassays, flow cytometry, ELISA, and qPCR.Maintain lab readiness by coordinating with internal/external resources and handling routine record review for in-process testing and releases.Support generation of CoAs for product release and monitor data trends.Maintain calibration and routine maintenance of laboratory instruments.Author or revise SOPs, qualification/validation protocols, and reports.Assist with OOS investigations and determine root causes for analytical deviations.Provide updates at daily/weekly meetings and monitor GMP systems for compliance.Review proposed changes to systems, procedures, methods, and regulatory submissions as appropriate.Gather metrics for continuous improvement of responsibilities.Perform other duties as required.Key requirementsBachelor's degree OR AA degree with 2+ years in biotechnology or related field and Quality Control experience OR High School degree with 3+ years in biotechnology or related field and Quality Control experienceStrong written and verbal communication skillsAbility to work independently with scientific/technical personnelCollaborative and detail-orientedGMP knowledgeSOP development and revisionOOS investigations and root-cause analysis