Quality Assurance Engineer
On-siteCharles City, Iowa, United States
Charles City, Iowa, United StatesOn-siteFull TimeLarge
Full TimeLarge
Job Summary
Review customer specifications, stability data, and technical documents to support regulatory needs and compile relevant data for Cambrex Charles City products. Serve as the liaison for regulatory filings by coordinating CEPs, Letters of Authorization, and EDMF/CDMF submissions with MAA while managing customer complaints and inquiries. Assess change controls for compliance with regulatory submissions and review data from R&D, manufacturing, and supply chain departments to correspond with customers. Compile and author Annual Product Quality Reviews while adhering to DEA, EPA, FDA, and cGMP regulations.
Required Qualifications
- Ability to maintain written and oral communication in English
- Strong critical thinking skills
- Strong interpersonal and leadership skills
- BS or BA
- 3-5 years of relevant experience
- Experience in a cGMP environment
- Experience at a commercial manufacturing facility for pharmaceuticals
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