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Biofire Diagnostics - Durham, NC
posted about 2 months ago
About the position
The QC Biochemistry Analyst 1 role at BioFire Diagnostics is focused on routine biochemistry testing within a fast-paced, FDA-regulated environment in the Medical Devices/Diagnostics industry. This position involves performing various tests on raw materials, intermediates, and finished products, ensuring compliance with standard operating procedures (SOPs) and good documentation practices (GDP). The role requires working night shifts on a 2-2-3 rotation schedule, emphasizing accuracy, thoroughness, and timely documentation of test results.
Responsibilities
- Perform routine biochemistry testing on raw materials, intermediates, and finished products.
- Ensure all testing documentation is completed accurately and in a timely manner.
- Maintain compliance with SOPs, GLP, GMP, and HSE requirements.
- Prepare for regulatory, customer, and internal audits of the Biochemistry laboratory.
- Execute laboratory investigations as assigned by management.
- Enter data into the laboratory information management system (LIMS) and assist with LIMS maintenance.
- Ensure personal training is up to date with current department processes and procedures.
- Utilize personal protective equipment (PPE) as required for laboratory duties.
- Participate in continuous improvement activities and maintain a clean laboratory environment.
Requirements
- Bachelor's degree with 0 years of experience required.
- High school diploma/GED with 4+ years of experience in a regulated laboratory environment, or an Associate's Degree with 2+ years of experience accepted in lieu of a Bachelor's Degree.
- Lab experience in Biochemistry or Chemistry is highly desired.
- Technical and scientific knowledge of relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP) preferred.
- Experience with software tools for data entry and analysis (LIMS) is preferred.
- Advanced technical writing skills preferred.
- Experience with chemistry or biochemistry testing and knowledge of USP and EP/BP method/validation regulations preferred.
- Experience handling chemicals in a lab environment (academic or professional) is preferred.
Nice-to-haves
- BS degree in Biochemistry, Chemistry, or Biology is preferred.
