GMP Quality Control Analyst II — Stability & Compliance

Lonza; Walkersville (MD); On-site; USD 70,000 - 82,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

401(k) matching plan

Life insurance

Short-term disability

Long-term disability

Employee assistance programs

Paid time off

Performance-related bonus

Job summary

Lonza in Walkersville, MD seeks a Quality Control Analyst II 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 while ensuring regulatory compliance.

The ideal candidate will review data, support stability protocol execution, manage samples, and participate in investigations.

Qualifications

• Associate degree or equivalent with GMP lab experience preferred
• Minimum 3 years in a pharmaceutical, biotech, life sciences, or other regulated lab environment
• Experience supporting GMP stability programs, sample management, testing coordination, and documentation
• Knowledge of analytical laboratory techniques, aseptic practices, and GMP laboratory operations
• Strong written and verbal communication; ability to multitask across priorities

Responsibilities

• Perform routine and moderately complex testing of in-process, release, environmental, and stability samples
• Review, analyze, and interpret data to ensure accurate reporting of results
• Support GMP stability programs, including protocol execution, sample inventory management, testing coordination, and documentation review
• Participate in laboratory investigations, deviations, OOS, and atypical results, identifying root causes
• Author, revise, and maintain SOPs, test methods, protocols, reports, and GMP documentation
• Train and support laboratory personnel on analytical techniques, procedures, and best practices
• Assist with method transfers, validation activities, equipment qualification, and continuous improvement projects
• Support day-to-day laboratory operations, including sample management and inventory control

Skills

Analytical skills

Troubleshooting

Problem-solving

Organization

Communication

Education

Associate degree

Tools

Laboratory equipment

Job description

Lonza in Walkersville, MD seeks a Quality Control Analyst II 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 while ensuring regulatory compliance.

The ideal candidate will review data, support stability protocol execution, manage samples, and participate in investigations.