QC Senior Scientist- Raw Materials
On-sitePortsmouth, New Hampshire, United States
Job Summary
Perform laboratory testing to support method transfers, validations, investigations, and routine quality control activities for raw materials. Author and review technical documents, protocols, and test methods while ensuring compliance with GMP and data integrity requirements. Lead or support validation, transfer, and investigation activities, including setting up and verifying laboratory equipment and electronic templates. Investigate laboratory events, identify root causes, and support corrective actions through completion. Train and mentor colleagues on laboratory methods and procedures, driving continuous improvement initiatives to enhance efficiency. Act as a subject matter expert on Raw Material compliance, supporting audits and collaborating with cross-functional teams. This role operates within a fast-paced GMP environment at Lonza, supporting the delivery of life-changing therapies.
Required Qualifications
- Bachelor's degree in Chemistry, Biochemistry, or related scientific discipline
Desired Qualifications
- Advanced degree (MS or PhD)
- Experience in a GMP-regulated laboratory, pharmaceutical, biotechnology, or related environment
- Experience with pharmaceutical compendia
- Knowledge of analytical testing, method transfers, and method validation principles
- Experience with quality systems such as LIMS, TrackWise, DMS, or electronic laboratory notebooks
- Strong technical writing, documentation, and data review skills
- Ability to analyze data, troubleshoot issues, and identify solutions
- Strong organizational and time management skills with the ability to manage multiple priorities
- Excellent written and verbal communication skills
- Proficiency with Microsoft Office applications including Word, Excel, and PowerPoint
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