QC Chemist – GMP Analytics & Lab Excellence

Lonza Group Ltd.; Tampa (FL); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Professional development

Competitive compensation and benefits

Job summary

Lonza Group Ltd. in Tampa, FL seeks a skilled analytical testing professional to support manufacturing and product release activities in a GMP-regulated environment.

You will operate HPLC/UPLC and other analytical systems, document data per ALCOA+ and assist with method validation, investigations, and continuous improvement across Quality, Manufacturing, Validation, and Regulatory teams.

Qualifications

• Experience performing analytical testing within a GMP-regulated pharmaceutical, biotechnology, or life sciences laboratory environment.
• Hands-on expertise with analytical techniques such as HPLC, UPLC, FTIR, UV-Vis spectroscopy, Dissolution, TOC, titration, and other wet chemistry methods.
• Working knowledge of cGMP regulations, data integrity principles, and regulatory expectations from agencies such as FDA, EMA, and USP.
• Experience documenting, reviewing, and interpreting analytical data, laboratory investigations, and technical reports.

Responsibilities

• Perform analytical testing of raw materials, in-process, stability, environmental monitoring, water, and finished product samples to support manufacturing and product release activities.
• Operate and maintain laboratory instrumentation including HPLC, UPLC, Dissolution, FTIR, UV-Vis, TOC, and other analytical systems while ensuring data integrity and compliance.
• Generate accurate laboratory documentation and reports in accordance with cGMP, GDP, ALCOA+, and regulatory requirements.
• Investigate laboratory deviations, out-of-specification (OOS), out-of-trend (OOT), and other quality events while supporting CAPA activities.
• Collaborate with Quality, Manufacturing, Validation, and Regulatory teams to ensure timely and compliant testing support.
• Support method validation, method transfer, equipment qualification, training activities, internal audits, and regulatory inspections.
• Contribute to continuous improvement initiatives that enhance laboratory efficiency, quality performance, and operational excellence.

Skills

Analytical testing

Regulatory knowledge

Data integrity

Tools

HPLC

UPLC

FTIR

UV-Vis

Dissolution

TOC

Job description

Lonza Group Ltd. in Tampa, FL seeks a skilled analytical testing professional to support manufacturing and product release activities in a GMP-regulated environment.

You will operate HPLC/UPLC and other analytical systems, document data per ALCOA+ and assist with method validation, investigations, and continuous improvement across Quality, Manufacturing, Validation, and Regulatory teams.