Chemist I

The Chemist I performs routine laboratory analytical testing, documentation, and reporting for potent and non-potent pharmaceutical drug products and drug substances in a GMP laboratory. This role supports product quality through analytical testing, accurate recordkeeping, instrument troubleshooting, laboratory investigations, root cause analysis, and participation in daily tier processes. The ideal candidate has a strong foundation in laboratory equipment, cGLP/cGMP principles, and continuous improvement practices.

Responsibilities:

• Perform routine laboratory analytical testing of potent and non-potent pharmaceutical drug products and drug substances.
• Conduct analytical tests, including dissolution, assay/degradate, content uniformity, and identity testing.
• Document and report laboratory results accurately in accordance with GMP requirements.
• Operate routine laboratory equipment, including Karl Fischer titrators, pH meters, conductivity meters, UV instruments, HPLC systems, and dissolution apparatus.
• Participate in laboratory investigations and root cause analysis to support the resolution of quality issues.
• Perform basic troubleshooting of laboratory instrumentation and assist with resolving equipment-related issues.
• Participate in daily tier processes and support laboratory operations.
• Apply continuous improvement principles to enhance laboratory efficiency, consistency, and compliance.
• Follow applicable regulatory requirements and cGLP/cGMP principles when performing laboratory activities.
• Prepare and update technical documentation, including standard operating procedures and quality notifications, as needed.

Education:

Required: Bachelor's degree in Chemistry, Biology, Engineering, or another STEM-related field.

Required Skills:

• Knowledge of continuous improvement principles, including 5S, Kaizen, Hoshin, and Standard Work.
• Knowledge of routine laboratory equipment operation, including Karl Fischer, pH meters, conductivity meters, UV instruments, HPLC systems, and dissolution apparatus.
• Knowledge of regulatory requirements, cGLP, and cGMP principles.
• Experience using Microsoft Office applications, including Word, Excel, and Outlook.
• Preferred Skills
• Experience operating laboratory equipment such as HPLC, dissolution apparatus, FTIR, and NIR.
• Experience using Empower chromatography data software.
• Experience using LabWare/LIMS.
• Experience conducting root cause analysis.
• Technical writing experience, including updating standard operating procedures and preparing quality notifications.
• Knowledge of tier processes.
• Experience applying continuous improvement principles, including 5S, Kaizen, Hoshin, and Standard Work.

Additional Information
Location: Wilson, North Carolina.
This role supports pharmaceutical quality and compliance through routine analytical testing, laboratory documentation, investigations, and continuous improvement activities.
Attention to detail and adherence to laboratory procedures and GMP requirements are essential.