Quality Control Chemist II

7 days ago


Charles City, Iowa, United States Cambrex High Point Full time
About the Role

Cambrex High Point is seeking a highly skilled Quality Control Chemist II to join our team. As a key member of our laboratory team, you will be responsible for ensuring the quality of our products and processes.

Key Responsibilities
  • Adhere to all regulatory requirements, including EPA, FDA, cGMP, and cGLP regulations, as well as internal SOPs.
  • Follow all safety protocols and practices, including OSHA and company rules.
  • Perform a wide variety of chemical analyses for release of raw materials, in-process, intermediates, finished goods, and stability.
  • Maintain and support laboratory programs, including calibration, preventive maintenance, IQ/OQ/PQ.
  • Investigate non-complying test results and troubleshoot equipment.
  • Write controlled documents, including reports, test procedures, and SOPs.
  • Evaluate the validity of test results and provide recommendations.
  • Independently handle, analyze, and dispose of hazardous samples and waste.
  • Provide off-shift coverage as required.
  • Maintain laboratory solutions, inventory, and notebooks.
  • Assist in training employees as needed.
  • Coordinate and communicate project status.
  • Interact with outside vendors and other departments.
Requirements
  • BS/BA in Chemistry or related science field required.
  • Advanced degree (MS, PhD) in Chemistry or related science field preferred.
  • Three years of laboratory cGMP experience, preferably in a NLT 5-year environment.
  • Strong cGMP experience and knowledge of analytical instrumentation.
  • Working knowledge of chromatography, wet chemistry, and NMR, DSC, IC, and/or ICP-OES.
  • Strong chemistry theory and ability to handle various project loads.
  • Ability to work in a fast-paced, deadline-driven work environment.
  • Strong attention to detail and effective communication skills.
  • Ability to work well with others in a team environment and independently with little or no direct supervision.
About Cambrex High Point

Cambrex High Point is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. We are committed to providing a safe and productive work environment and are an Equal Opportunity / Affirmative Action employer.



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