Night Shift QC Biochemistry Analyst II – Training & Audits

bioMerieux; Durham (NC); On-site; USD 33,000 - 50,000; Full time

Benefits offered by this job

Medical, dental, and vision plans

Telemedicine options

Life and Accidental Death Insurance

Disability insurance

Retirement plan with employer match

Job summary

bioMérieux in North Carolina is seeking a Quality Control Biochemistry Analyst 2 to perform routine Biochemistry testing and ensure product safety and efficacy prior to release. The role involves testing raw materials, intermediates, and finished products, training staff, troubleshooting equipment, and maintaining documentation in accordance with SOPs, GLP, GMP and GDP.

Candidates typically have a High School diploma with 4+ years of related biochemistry lab experience; a Bachelor's degree is

Qualifications

• High School Diploma, GED or equivalent.
• 4+ years of related experience – Experience working in a regulated Biochemistry or Chemistry laboratory (FDA, ISO, USDA, etc.) with GxP testing.
• Bachelor's degree in Chemistry, Biochemistry, or Biomedical preferred.
• Experience with LIMS and data entry/analysis.
• Experience participating in regulatory audits (FDA, ISO, OSHA, etc.).
• Knowledge of ISO/QSR/Quality principles.

Responsibilities

• Train QC testing and instrument maintenance.
• Troubleshoot Biochemistry lab equipment.
• Ensure testing documentation is accurate and compliant with GDP.
• Review laboratory testing per SOPs and complete timely.
• Maintain SOP, GLP, GMP, and HSE compliance.
• Prepare for regulatory audits and support investigations.
• Enter data into LIMS and support validation activities.
• Assist with revisions to QC SOPs as directed.
• Maintain personal training on processes.
• Use PPE as required.
• Support improvement initiatives.
• Collaborate with other departments on validation protocols.

Skills

Written Communications

MS Office

Verbal Communication

Problem Solving

Education

High School Diploma

Bachelor's degree in Chemistry/Biochemistry

Tools

LIMS

Excel

Job description

bioMérieux in North Carolina is seeking a Quality Control Biochemistry Analyst 2 to perform routine Biochemistry testing and ensure product safety and efficacy prior to release. The role involves testing raw materials, intermediates, and finished products, training staff, troubleshooting equipment, and maintaining documentation in accordance with SOPs, GLP, GMP and GDP.

Candidates typically have a High School diploma with 4+ years of related biochemistry lab experience; a Bachelor's degree is