QC Chemist – Analytical Lab (Drug Substances)

Cambrex Corp.; Charles City (IA); Vor Ort; USD 48.000 - 75.000; Vollzeit

Benefits dieser Stelle

Competitive benefits

Healthcare

Life insurance

Retirement planning

Zusammenfassung

Cambrex Charles City in Iowa seeks a Chemist I in Quality Control to perform chemical analyses ensuring release of materials and products. The role emphasizes compliance with EPA, FDA, cGMP, cGLP, and DEA regulations.

You will contribute to lab programs, calibration, preventive maintenance, method development, and troubleshooting of analytical instruments, while handling hazardous materials and providing data reviews.

Qualifikationen

• BS/BA in Chemistry/Biology or related science required.
• Three years laboratory cGMP environment (preferred NLT 5 years) with a BS or advanced degree.
• Experience testing against USP/EP compendia and working knowledge of GC/HPLC instrumentation.

Aufgaben

• Adhere to EPA, FDA, cGMP, cGLP, DEA regulations and internal SOPs in QC lab.
• Perform chemical analyses for release of raw materials, in-process materials, intermediates, finished goods, and stability.
• Maintain calibration and preventive maintenance programs for laboratory instruments.
• Troubleshoot analytical instruments and transfer methods from Analytical Development.
• Write controlled documents such as reports and SOPs; evaluate test results for validity.
• Provide off-shift coverage and collaborate with other departments as needed.

Kenntnisse

cGMP experience

Analytical instrumentation (GC, HPLC)

NMR/DSC/IC/ICP-OES knowledge

Chemistry theory

Attention to detail

Communication skills

Teamwork

Independent work

Mass spectrometry experience

Ausbildung

BS/BA in Chemistry/Biology or related science

MS/PhD in Chemistry/Biology or related science (preferred)

Tools

GC

HPLC

NMR

DSC

IC

ICP-OES

Jobbeschreibung

Cambrex Charles City in Iowa seeks a Chemist I in Quality Control to perform chemical analyses ensuring release of materials and products. The role emphasizes compliance with EPA, FDA, cGMP, cGLP, and DEA regulations.

You will contribute to lab programs, calibration, preventive maintenance, method development, and troubleshooting of analytical instruments, while handling hazardous materials and providing data reviews.