Quality Control Specialist — cGMP Lab Leader

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Opportunities to grow and develop your

Collaborative laboratory environment

Compensation programs that recognize高

Job summary

Lonza in Portsmouth, New Hampshire, is seeking a Quality Control professional to support manufacturing, stability, environmental monitoring, and product release activities in a cGMP‑regulated environment.

You will perform laboratory assays, analyze data, troubleshoot equipment, and support investigations and CAPAs, using LIMS, TrackWise, and other electronic systems, while mentoring others and contributing to continuous improvement.

Qualifications

• Associate's or Bachelor's degree in life science or related field preferred.
• Minimum of 3+ years in a GMP, pharmaceutical, biotechnology, environmental, microbiology, or quality control laboratory environment.
• Experience performing laboratory testing and working with analytical or microbiological methods.
• Experience using laboratory systems such as LIMS, TrackWise, DMS, or similar electronic systems preferred.
• Strong ability to analyze data, recognize trends, and investigate potential issues.
• Knowledge of cGMP regulations, data integrity principles, and documentation practices.
• Strong communication, collaboration, and problem-solving skills.

Responsibilities

• Perform quality control testing to support manufacturing, stability programs, environmental monitoring, and product release activities.
• Execute laboratory assays and analytical techniques in accordance with approved procedures and cGMP requirements.
• Analyze and interpret data, ensuring accurate and timely reporting of results.
• Troubleshoot laboratory equipment, test methods, and system-related issues.
• Support investigations, deviations, CAPAs, and other quality system activities.
• Utilize laboratory systems such as LIMS, TrackWise, DMS, or similar electronic quality systems.
• Support training, mentoring, and knowledge sharing across the laboratory while contributing to continuous improvement initiatives.

Skills

Analytical thinking

Laboratory testing

GMP knowledge

Communication

Education

Associate's or Bachelor's in life sciences

Tools

LIMS

TrackWise

DMS

Job description

Lonza in Portsmouth, New Hampshire, is seeking a Quality Control professional to support manufacturing, stability, environmental monitoring, and product release activities in a cGMP‑regulated environment.

You will perform laboratory assays, analyze data, troubleshoot equipment, and support investigations and CAPAs, using LIMS, TrackWise, and other electronic systems, while mentoring others and contributing to continuous improvement.