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Analytical Development Specialist

2 months ago

Bend, Oregon, United States Maxonic Full time
Job Description:

Key Responsibilities:

  • Perform testing using various analytical techniques, such as HPLC, Dissolution, GC, PXRD, FT-IR, DSC, and KF.
  • Record and report results of analyses in accordance with lab procedures, GDP, and ALCOA.
  • Create documentation detailing results (e.g. Certificate of Testing, Reports, PowerPoint Slides).
  • Review and interpret analytical test results. Make recommendations based on data.
  • Conduct method development experiments designed by SMEs.
  • Write and execute method validations.
  • Recognize and report deviations, validation discrepancies, or unexpected results.
  • Maintain a clean and organized laboratory workspace consistent with management expectations.
  • Clean and calibrate analytical instrumentation as needed.
  • May interact with customers and auditors.
  • Collaborate with various functional areas to meet project and team objectives.
  • Manage projects at the task level under minimal supervision.
  • Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintain the necessary compliance status required by company and facility standards.
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.

Equivalency:

  • Equivalent combinations of education, training, and relevant work experience may be considered.

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).
  • Good attention to detail and critical and logical thinking skills.
  • Ability to read, analyze, and interpret technical procedures and governmental regulations.
  • Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
  • Ability to work on multiple projects simultaneously.

Physical Requirements:

  • Typically requires standing and walking for a shift.
  • Occasionally requires lifting of up to 20 pounds.
  • Requires manual dexterity and visual abilities.