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Senior Quality Control Chemist

2 months ago

Charles City, Iowa, United States Cambrex Full time
{"Responsibilities": "Key Responsibilities
  • Ensure compliance with EPA, FDA, cGMP, cGLP, and DEA regulations in the Quality Control lab and chemical production facility.
  • Adhere to OSHA and company safety rules and practices.
  • Conduct data review and entry.
  • Perform a wide range of chemical analyses for raw materials, in-process, intermediates, finished goods, and stability.
  • Maintain and support laboratory programs, including calibration, preventive maintenance, IQ/OQ/PQ.
  • Investigate non-compliant test results.
  • Develop working knowledge of chromatography and wet chemistry.
  • Write controlled documents, such as reports, test procedures, and SOPs.
  • Evaluate test result validity.
  • Troubleshoot equipment independently.
  • Perform and document method transfers 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.
  • Assist in training employees as needed.
  • Coordinate and communicate project status.
  • Interact with outside vendors and other departments.
  • Develop extensive knowledge of 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.
", "Qualifications": "Requirements
  • Bachelor's degree in Chemistry, Biology, or related science field required.
  • Advanced degree (MS, PhD) in Chemistry, Biology, or related science field preferred.
  • Three years of laboratory cGMP experience (preferred NLT 5 years) with a BS or advanced degree.
  • 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 loads.
  • 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 environment.
  • Ability to work independently with little or no direct supervision.
  • Mass Spectrometer experience preferred.
", "company_info": "

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.

", "lang_code": "en-US"}