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Regulatory Compliance Specialist

2 months ago

Bend, Oregon, United States Indotronix Avani Group Full time
Job Summary

Indotronix Avani Group is seeking a highly skilled Scientist I to join our team in a Regulated Laboratory Environment. As a key member of our scientific team, you will be responsible for performing method development, method validation, and analytical testing activities for clinical development materials.

Key Responsibilities
  • Method Development and Validation: Develop, validate, and execute analytical methods for clinical development materials.
  • Analytical Testing: Perform testing using various analytical techniques, including HPLC, Dissolution, GC, PXRD, FT-IR, DSC, and KF.
  • Documentation and Reporting: Record and report results of analyses in accordance with lab procedures, GDP, and ALCOA. Create documentation detailing results, including Certificate of Testing, Reports, and PowerPoint Slides.
  • Regulatory Compliance: Ensure all activities are performed in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
Requirements
  • Education: Bachelor of Science in Chemistry, Biochemistry, Biology, or related physical science.
  • Experience: At least 1 year of experience working in a regulated laboratory environment. GMP experience preferred.
  • Competencies: Hands-on experience with various analytical techniques, including HPLC, GC, Dissolution. Ability to work independently and in a team setting. Strong knowledge of Good Manufacturing Practices and data integrity (ALCOA).