QC Analyst

Position Summary

Durham, NC.

Schedule:

Monday–Friday, 3:00 PM – 11:30 PM. The QC Biochemistry Analyst 2 role is responsible for routine Biochemistry testing.

• Testing of raw materials, intermediates, special test requests, and finished product samples per standard operating procedures.
• Investigational writing of INVALID reports.
• Provide input and support for Out of Specification reports.
• Serve as a certified trainer for laboratory testing as applicable.

• Participate as a trainer for Quality Control testing and instrument maintenance.
• Troubleshoot simple to moderate Biochemistry laboratory equipment related issues.
• Ensure all testing documentation is completed accurately, thoroughly, and timely.
• Ensure review of laboratory testing is performed in compliance with SOPs and in a timely manner.
• Maintain compliance with SOPs, GLP, GMP, and HSE requirements.
• Prepare for regulatory, customer, and internal audits of Biochemistry laboratory areas.
• Execute laboratory investigations as assigned by management in compliance with procedures.
• Provide input for laboratory investigations and document invalid test results in compliance with procedures.
• Enter data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assist with LIMS data entry to support LIMS maintenance and validation activities.
• Assist with revisions to QC department standard operating procedures (SOPs) as directed by management.
• Ensure personal training is maintained to current department processes and procedures.
• Appropriately utilize PPE as required to perform routine and non-routine laboratory duties.
• Participate in improvement initiatives as directed by management.
• Work with other departments to execute validation protocols associated with Biochemistry laboratory equipment, associated software, and procedures, including revalidation as scheduled or required to maintain systems in a validated state.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

• High School Diploma, GED or equivalent.
• 4+ years of experience working in a regulated Biochemistry or Chemistry laboratory (FDA, ISO, USDA, etc.) with GxP testing.

• Bachelor's degree highly preferred in Chemistry, Biochemistry, or Biomedical.
• 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.
• Experience participating in the management of regulatory audits (e.g., FDA, MDSAP, ISO, OSHA, EPA, etc.).
• Knowledge in the interpretation and application of relevant domestic and international regulations and industry standards (e.g., ISO, QSR, UL, CSA, VDE, etc.).
• Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations.

• Ability to remain in a stationary position, either sitting or standing, for prolonged periods.
• Ability to wear PPE correctly most of the day.
• No ability required for ascending/descending stairs, ladders, ramps, etc.
• No ability required to operate heavy machinery.
• No requirement to adjust or move objects up to 50 pounds in all directions.
• Domestic travel required: 0%.
• International travel required: 0%.

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Written Communications – ability to communicate technical data in written form.
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel – intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance.
• Excellent and effective verbal and written communication skills.
• Proven ability to problem solve/troubleshoot and provide solutions under minimal supervision.
• Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.

The estimated salary…