Position Summary: The normal working hours for this position are night shift: 7:00pm - 7:30am working a 2-2-3 rotation schedule. The QC Biochemistry Analyst 1 role is responsible for routine Biochemistry testing. The responsibilities of this position include Investigational writing & testing of raw materials, intermediates, special test requests, stability, and finished product samples per standard operating procedure. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry Analyst 1 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. Primary Responsibilities: + Quality + Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements. + Ensures review of laboratory testing is done in compliance with SOPs and is completed in a timely manner. + Maintains compliance with SOPs, GLP, GMP, and HSE requirements. + Prepares for regulatory, customer, and internal audits of Biochemistry laboratory areas. + Preparation includes review of logbooks, instrument calibration dates, material expirations, and general cleanliness of laboratory area. + Executes laboratory investigations as assigned by management in compliance with procedures. + Provides input for laboratory investigations and documents invalid test results in compliance with procedures. + Documentation/Training + Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assists with LIMS data entry to support LIMS maintenance and validation activities. + Ensures personal training is maintained to current department processes and procedures. + Safety: Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties. + Continuous Improvement + Participate in continuous improvement activities. + 6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner in compliance with cGLP. + Performs additional job-related duties as assigned by management. Education, Skills, & Experience: + Bachelor's degree with 0 years of experience required. + In lieu of a Bachelor’s Degree, a high school diploma/GED with 4+ years of experience in a regulated laboratory environment OR an Associate’s Degree with 2+ years of experience working in a regulated laboratory environment, also accepted + Lab experience in Biochemistry or Chemistry highly desired + BS degree in Biochemistry, Chemistry, or Biology is preferred + Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP) preferred. + Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills preferred. + Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations preferred. + Experience handling chemicals in a lab environment (academic or professional) is preferred #biojobs