Quality Control Chemist - Days

NCSL International; Charles City (IA); Hybrid; USD 55,000 - 75,000; Full time

Job summary

Cambrex Charles City is seeking a Chemist I in Quality Control to perform a variety of chemical analyses ensuring release of materials and products, with adherence to EPA, FDA, cGMP, cGLP and DEA regulations.

You will develop and maintain laboratory programs, support method development, handle hazardous materials, conduct data reviews, and provide on-call support as needed while working with cross-functional teams.

Qualifications

• BS/BA in Chemistry or Biology or related science field required
• Advanced degree (MS/PhD) preferred
• Three years laboratory cGMP environment experience with BS or higher or advanced degree

Responsibilities

• Adhere to EPA, FDA, cGMP, cGLP and DEA regulations and SOPs in QC lab operations
• Perform chemical analyses for raw materials, in-process, intermediates and finished goods
• Maintain/calibrate/PM lab instruments and IQ/OQ/PQ programs
• Write and review reports, SOPs and test procedures
• Troubleshoot analytical instruments and perform method transfer from development
• Handle hazardous samples and waste and provide on-call coverage as needed

Skills

cGMP experience

USP/EP testing

GC/HPLC knowledge

NMR/DSC/IC/ICP-OES knowledge

Chemistry theory

Project load management

fast-paced environment

Attention to detail

Communication skills

Teamwork & independence

Mass spectrometry

Education

BS or higher in Chemistry/Biology

MS/PhD preferred

Job description

Cambrex

Quality Control Chemist - Days

US-IA-Charles City

Job ID: 2026-4796

Type: Regular Full-Time

# of Openings: 1

Category: Quality Control

Cambrex - Charles City

Overview

The Chemist I in Quality Control is responsible for performing a variety of chemical analyses to ensure the release of raw materials, intermediates, and finished products. The role requires adherence to EPA, FDA, cGMP, cGLP, and DEA regulations, as well as company SOPs. The Chemist I also contributes to the development and maintenance of laboratory programs, such as stability testing, calibration, and preventive maintenance, and participates in method development and troubleshooting for analytical instruments. The position involves handling hazardous materials, conducting statistical evaluations of data, and providing on-call support as needed.

Responsibilities

• Adhere to all EPA, FDA, cGMP, cGLP DEA regulations and internal SOP's as they relate to the operation of the Quality Control lab and general operation of the chemical production facility
• Follow all OSHA and company safety rules and practices
• Data review
• Data entry
• Perform a wide variety of chemical analyses for release of raw materials, in-process, intermediates, finished goods, and stability
• Maintain/support laboratory programs such as calibration/preventive maintenance, IQ/OQ/PQ
• Perform in-depth laboratory investigations of non-complying test results.
• Working knowledge of chromatography
• Working knowledge of wet chemistry
• Write controlled documents such as reports, test procedures, SOPs, etc.
• Evaluate validity of test results
• Independently troubleshoot equipment
• Perform and document method transfer from Analytical Development
• Run method evaluation experiments
• Handle, analyze and dispose of hazardous samples and waste
• Provide off-shift coverage as required
• Maintain laboratory solutions, inventory and notebooks
• Responsible for assisting in training employees as needed both inside and outside the department
• Coordinate and communicate project status
• Interacting with outside vendors and other departments
• Extensive knowledge and proven ability to use a wide assortment of the analytical instrumentation available at Cambrex Charles City.
• Proven ability to handle various assignments and organize workload to meet timelines
• Act as departmental subject matter expert (SME)
• All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.

Qualifications / Skills

• Strong cGMP experience
• Experience testing against USP and EP compendia.
• Working knowledge of analytical instrumentation (GC, HPLC minimum)
• Working knowledge of NMR, DSC, IC, and/or ICP-OES preferred
• Strong chemistry theory
• Proven ability to handle various project load is preferred
• Ability to work in a fast-paced, deadline driven work environment
• Strong attention to detail
• Effective communication skills (oral, written)
• Ability to work well with others in a team environmentAbility to work independently with little or no direct supervision
• Mass Spectrometer experience preferred

Qualifications

• BS/BA in Chemistry/Biology or related science field required
• Advanced degree (MS, PhD) in Chemistry/Biology or related science field preferred
• Three years laboratory cGMP environment (preferred NLT 5 years) with a BS or advanced degree

PI287510828