QC Environmental Monitoring Lead — Elevate Testing Quality

bioMerieux; Durham (NC); On-site; USD 59,000 - 88,000; Full time

Benefits offered by this job

Medical plans

Dental & vision

Life Insurance

Disability Insurance

Retirement plan

Wellness programs

Employee assistance

Commuter benefits

Parental leave

Job summary

bioMérieux seeks a QC Lead Analyst (EM) to lead the Environmental Monitoring team, oversee testing, and ensure regulatory compliance. You will mentor staff, manage investigations, and drive continuous improvement in testing quality and data integrity across the lab.

The role focuses on leadership, SOP maintenance, and collaboration to sustain GDP-compliant operations in a fast-paced FDA-regulated environment.

Qualifications

• Bachelor degree or 4 years of additional relevant experience in a regulated lab.
• Experience in Environmental Monitoring or Microbiology lab with GxP testing.
• Knowledge of GMP/GLP and regulatory audits is preferred.

Responsibilities

• Leads the QC Environmental Monitoring team and manages daily scheduling and team performance.
• Mentors staff, drives training, and supports development of high-performing employees.
• Oversees environmental monitoring testing (bioburden, conductivity, TOC) and sampling for materials, finished products, air, water, and surfaces.
• Maintains GDP-compliant documentation and data integrity across QC activities.
• Leads investigations (OOS, NC, CI, CAPA) and supports regulatory audits as SME.
• Recommends SOP revisions and process improvements; supports data trending and LIMS data entry.

Skills

Leadership

GxP testing

Regulatory knowledge

LIMS

Data integrity

SOP development

Education

Bachelor degree

4 years relevant experience

Tools

LIMS

MS Office

Job description

bioMérieux seeks a QC Lead Analyst (EM) to lead the Environmental Monitoring team, oversee testing, and ensure regulatory compliance. You will mentor staff, manage investigations, and drive continuous improvement in testing quality and data integrity across the lab.

The role focuses on leadership, SOP maintenance, and collaboration to sustain GDP-compliant operations in a fast-paced FDA-regulated environment.