GMP QC Analyst II - Lab & Stability

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

Benefits offered by this job

Performance bonus

Medical insurance

Dental insurance

Vision insurance

401(k) matching

Life insurance

Disability insurance

Employee assistance program

Paid time off

Job summary

Lonza in Walkersville, MD is seeking a Quality Control Analyst II to perform routine and moderately complex GMP lab testing. You will analyze data, support stability programs, and assist with investigations and documentation in a collaborative, regulated environment.

The role requires an associate degree or technical certification with at least 3 years in a pharmaceutical/biotech lab, plus strong analytical and communication skills. On-site, typical hours are Mon–Fri, 8:00–5:00 EST.

Qualifications

• Associate degree or technical certification or equivalent lab experience preferred.
• Minimum 3 years in a pharmaceutical/biotech/regulatory lab environment.
• Experience supporting GMP stability programs and documentation.
• Knowledge of analytical lab techniques and GMP operations.
• Familiarity with GMP regulations and data integrity principles.
• Strong written and verbal communication skills.

Responsibilities

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

Skills

GMP laboratory experience

Analytical techniques

Aseptic practices

GMP regulations

Data integrity

Troubleshooting

Problem solving

Communication

Analytical thinking

Education

Associate degree / technical certification

Military laboratory training

Job description

Lonza in Walkersville, MD is seeking a Quality Control Analyst II to perform routine and moderately complex GMP lab testing. You will analyze data, support stability programs, and assist with investigations and documentation in a collaborative, regulated environment.

The role requires an associate degree or technical certification with at least 3 years in a pharmaceutical/biotech lab, plus strong analytical and communication skills. On-site, typical hours are Mon–Fri, 8:00–5:00 EST.