Position Summary & Responsibilities: The normal working hours for this position are 7:00am - 7:30pm working a 2-2-3 rotation schedule. The QC Biochemistry Analyst 3 role is responsible for routine Biochemistry testing and participation as a subject matter expert for laboratory instrumentation and processes. + Leadership + Serves as a subject matter expert for Quality Control instruments and processes. + Provides guidance and input as a certified co-investigator for Laboratory Incident Reports. + Leads as a mentor and trainer for Quality Control testing, instrument maintenance, investigational writing, and other laboratory processes. + Troubleshoots simple to moderate Biochemistry laboratory equipment related issues. + 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 for completion, instrument calibration checks, checking material expirations, and general cleanliness of laboratory area. + Participates in regulatory audits as a subject matter expert as needed. + Executes laboratory, non-conformance, and CAPA investigations as assigned by management in compliance with procedures. + Maintains status as a certified investigator for Out of Specification investigations. + 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. + Recommends and authors revisions to QC department standard operating procedures (SOPs) and executes in implementation. + Ensures personal training is maintained to current department processes and procedures. + Trains and mentor’s teammates on Biochemistry laboratory testing, processes, and procedures. + Maintains status as a certified trainer for laboratory testing processes. + Safety: Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties. + Continuous Improvement + Participate in continuous improvement activities. + Identify areas of deficiency and implement practices to improve employee safety, ergonomics, workflow/process design, etc. + Lead improvement initiatives as directed by management. + 6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner at all times in compliance with cGLP. + Other Duties + Work with other departments and assist with executing validation protocols associated with Biochemistry laboratory equipment, associated software, and procedures including revalidation as scheduled or required to maintain systems in a validated state. + Performs additional job-related duties as assigned by management. Education, Skills, & Experience: + Bachelor's degree with 4+ years of experience in a regulated laboratory environment, Chemistry or Biochemistry lab experience is highly preferred. + In lieu of a Bachelor’s Degree, a high school diploma/GED with 8+ years of experience OR an Associate’s Degree with a minimum of 6+ years of experience working in a regulated laboratory environment are also accepted + Technical writing experience is highly desired - Nonconformance, Laboratory Investigative Reports, CAPAs, Deviations, and SOPs + Experience troubleshooting equipment and instrumentation is highly preferred (HPLC, GC, PH, UV-VIS, or similar) + 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. #LI-US