Quality Control Chemist I: Precision Analytics & Compliance

Cambrex; Charles City (IA); On-site; USD 55,000 - 75,000; Full time

Job summary

Cambrex Charles City is hiring a Chemist I in Quality Control to perform a broad range of chemical analyses ensuring release of materials and finished products. The role requires compliance with EPA, FDA, cGMP and DEA regulations, plus involvement in method development, calibration, and troubleshooting of instruments.

You will maintain and document laboratory programs, support training, and coordinate with vendors and other departments to ensure timely project delivery.

Qualifications

• Experience in a cGMP laboratory environment applying GMP regulations.
• Experience testing against USP and EP compendia.
• Proficient with GC and HPLC instrumentation.
• Familiar with NMR, DSC, IC, or ICP-OES.
• Strong chemistry theory and analytical problem solving.
• Ability to manage multiple projects with deadlines.
• Excellent attention to detail and clear communication.
• Ability to work in a team and independently.
• Mass spectrometry experience is a plus.

Responsibilities

• Adhere to EPA, FDA, cGMP, cGLP DEA regulations and internal SOPs.
• Follow OSHA and safety rules.
• Data review.
• Data entry.
• Perform a wide variety of chemical analyses for release of materials, in-process, intermediates, finished goods, and stability.
• Maintain calibration/preventive maintenance, IQ/OQ/PQ.
• Investigate non-complying test results.
• Work with chromatography.
• Work with wet chemistry.
• Write reports, procedures, SOPs, etc.
• Evaluate validity of test results.
• Troubleshoot equipment independently.
• Transfer methods from Analytical Development.
• Run method evaluation experiments.
• Handle hazardous samples and waste.
• Provide off-shift coverage as required.
• Maintain lab solutions, inventory and notebooks.
• Assist in training employees.
• Coordinate and communicate project status.
• Interact with outside vendors and other departments.
• Utilize wide analytical instrumentation at Cambrex Charles City.
• Organize workload to meet timelines.
• Act as SME for the department.
• Adhere to all regulations and safety rules.

Skills

cGMP experience

USP/EP testing

GC/HPLC knowledge

NMR/DSC/IC/ICP-OES

Chemistry theory

multi-project management

fast-paced environment

attention to detail

communication skills

teamwork

independence

Mass spectrometry experience

Education

BS/BA in Chemistry/Biology or related science

MS/PhD preferred

3 years cGMP lab experience (NLT 5 years) with BS/advanced degree

Tools

GC

HPLC

NMR

DSC

IC

ICP-OES

Mass spectrometry

Job description

Cambrex Charles City is hiring a Chemist I in Quality Control to perform a broad range of chemical analyses ensuring release of materials and finished products. The role requires compliance with EPA, FDA, cGMP and DEA regulations, plus involvement in method development, calibration, and troubleshooting of instruments.

You will maintain and document laboratory programs, support training, and coordinate with vendors and other departments to ensure timely project delivery.