Quality Control Analyst - Environmental Monitoring, Cell Therapy

Lonza - Portsmouth, NH

Full-time - Entry Level

Portsmouth, NH

Professional, Scientific, and Technical Services

About the position

As a QC Environmental Monitoring (EM) Analyst at Lonza in Portsmouth, NH, you will play a crucial role in supporting the routine environmental monitoring of air, surfaces, and clean utilities involved in the manufacturing of in-process and final product drug lots for our customers. This position is integral to ensuring that our manufacturing processes meet the highest quality standards and regulatory requirements. You will be responsible for performing analyses of environmental monitoring in classified spaces and sampling various utilities, including water, clean air, and gas, in accordance with established procedures and test methods. In addition to environmental monitoring, you will analyze microbiological step samples in a laboratory setting and participate in quality testing to support ongoing customer needs. Your role will also involve reviewing assays and data to support trending and the release of manufacturing lots. As part of your responsibilities, you will provide guidance and training to junior staff or other departments, ensuring that all team members are equipped with the necessary knowledge and skills. You will also be tasked with writing, reviewing, and initiating Standard Operating Procedures (SOPs), Deviations, Corrective and Preventive Actions (CAPA), Change Control, Test Methods, and other quality documents. The level of this position will depend on your experience, allowing for growth and development within the role.

Responsibilities

• Perform analysis of environmental monitoring of classified spaces and sampling various utilities (water, clean air, gas) in accordance with procedures and test methods.
• Analyze microbiological step samples in a laboratory setting.
• Participate in quality testing for ongoing customer support.
• Review assays and data to support trending and manufacturing lot release.
• Provide guidance and training to junior staff or other departments.
• Write/review/initiate Standard Operating Procedures, Deviations, CAPA, Change Control, Test Methods and other Quality documents.

Requirements

• Associate Degree or higher required, Bachelor's preferred.
• Preferred area of study in Microbiology, Biochemistry or Related Science Fields.
• Entry level to working experience within industry in a quality control GMP manufacturing/laboratory setting.
• Previous experience using GMP Quality Systems (ex. TrackWise, LIMS, iLab, and Empower) preferred.
• Excellent communication skills with the ability to collaborate across multiple teams and projects.
• Ability to bend, crouch, and lift arms over head and lift up to 40 lbs.
• Ability to wear full gown for up to 50% of the shift when needed.
• Ability to multi-task and prioritize responsibilities.