GMP Quality Control Analyst I - Lab & Stability

Lonza; Walkersville (MD); On-site; Confidential; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Short-term and long-term disability

Job summary

Lonza in Walkersville, MD is seeking a Quality Control Analyst I to perform routine and moderately complex laboratory testing in support of GMP manufacturing and stability programs. This role blends hands-on execution with data analysis, investigations, and documentation to ensure compliant results.

The position is on-site, Monday–Friday, 8:00 AM–5:00 PM EST. Candidates should have an associate degree or equivalent and at least 2 years in a regulated lab, with experience in GMP stability,

Qualifications

• Associate degree, technical certification, military laboratory training, or equivalent combination of education and relevant laboratory experience preferred; GMP lab experience may count in lieu of degree.
• Minimum of 2 years of experience in a pharmaceutical/biotech or regulated lab setting.
• Experience supporting GMP stability programs, sample management, and documentation.

Responsibilities

• Perform routine and moderately complex lab testing of in-process, release, environmental monitoring, and stability samples.
• Conduct environmental monitoring in cleanroom environments using viable and non-viable methods.
• Review and interpret data to ensure accurate, timely reporting of results.
• Support GMP stability programs including protocol execution and inventory management.
• Participate in investigations (OOS/OOT/ environmental excursions) and assist with CAPAs and root-cause analysis.
• Author and maintain GMP documentation (SOPs, methods, protocols, reports).
• Train staff on analytical techniques and environmental monitoring practices.
• Support day-to-day lab operations and external coordination.

Skills

Lab testing

Data analysis

Documentation

Analytical thinking

Cross-team collaboration

Education

Associate degree or equivalent

Tools

GMP environment

Job description

Lonza in Walkersville, MD is seeking a Quality Control Analyst I to perform routine and moderately complex laboratory testing in support of GMP manufacturing and stability programs. This role blends hands-on execution with data analysis, investigations, and documentation to ensure compliant results.

The position is on-site, Monday–Friday, 8:00 AM–5:00 PM EST. Candidates should have an associate degree or equivalent and at least 2 years in a regulated lab, with experience in GMP stability,