QC Chemist — GMP Analytics & Lab Excellence

Lonza; Tampa (FL); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical, dental and vision insurance.

Competitive compensation programs

Professional development and career成长

Training and career growth within a全球性

Job summary

Lonza is seeking a QC Chemist to ensure safety, quality, and regulatory compliance through analytical testing and laboratory excellence. This site-based role emphasizes close in-person collaboration and precise testing to support product release and patient safety.

You will work with advanced analytical technologies, maintain data integrity, and contribute to CAPA and regulatory activities in a global life sciences setting.

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.
• Strong problem-solving, troubleshooting, and analytical thinking skills with a commitment to quality and accuracy.
• Ability to manage multiple priorities, meet testing timelines, and collaborate effectively within cross-functional teams.
• Bachelor's degree in chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline required.
• Must be available to work a 12-hour shift schedule, including days, nights, weekends, and holidays, as required.

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

GMP compliance

Data interpretation

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in chemistry, Biochemistry, Pharmaceutical Sciences, or related field

Tools

HPLC

UPLC

Dissolution

FTIR

UV-Vis

TOC

Job description

Lonza is seeking a QC Chemist to ensure safety, quality, and regulatory compliance through analytical testing and laboratory excellence. This site-based role emphasizes close in-person collaboration and precise testing to support product release and patient safety.

You will work with advanced analytical technologies, maintain data integrity, and contribute to CAPA and regulatory activities in a global life sciences setting.