bioMérieux QC Biochem Analyst Job Opening – Apply Now
Are you looking to launch your career in a dynamic, FDA-regulated laboratory setting? bioMérieux is hiring a QC Biochem Analyst 1 – Night Shift to join its manufacturing team in Durham, North Carolina. This is a great opportunity for recent graduates or experienced lab professionals who want to make a real impact in the field of medical diagnostics. If you’re passionate about quality control, lab science, and continuous improvement, this role is your perfect fit.
About bioMérieux
bioMérieux is a globally recognized leader in in vitro diagnostics, with a strong manufacturing presence in Durham, North Carolina. The company specializes in developing cutting-edge medical devices and diagnostic solutions that are vital to global healthcare systems. Operating in a fast-paced, FDA-regulated environment, bioMérieux is committed to delivering high-quality products that enhance patient care and safety. With decades of innovation and a clear focus on public health, bioMérieux is at the forefront of combating infectious diseases and supporting laboratory professionals around the world. Join us in our mission to improve lives through diagnostics.
Job Details:
Position: QC Biochem Analyst 1 – Night Shift
Location: Manufacturing, Durham, North Carolina
Job Description
- 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.
- 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
Keywords: bioMérieux, QC Biochem Analyst, Night Shift, Manufacturing, Durham, North Carolina, Medical Devices, Diagnostics
