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Quality Control Director
Location:
US-IN-Indianapolis
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Isotopia USA, a radioactive isotope manufacturing company, is seeking an experienced chemist that will be responsible for leading and managing the site Quality Control operations. The successful candidate will play a key role in the setup and qualification of the laboratory, as well as overseeing method validations and on-going testing of Isotopia products.

Job Responsibilities

  • Leading and managing analytical method development and validations for the various test specifications required for Isotopia products.
  • Overseeing the chemical and physical testing of raw materials, in-process and finished products, using established test methods to provide accurate and reliable data to assure their strength, identity and purity.
  • Training Quality Control staff to properly execute analytical tests.
  • Working with radioactive materials using safe protocols.
  • Maintaining accurate and complete lab data notebooks.
  • Records and reports results of analysis in accordance with prescribed lab procedures and systems.
  • Ensures the maintenance and calibration of analytical instruments within the QC laboratories.
  • Adhering to all applicable procedures, GMPs, company policies and any other quality or regulatory requirements.
  • Working well in a team environment.
  • Performing other duties as assigned.

Requirements

  • BS degree in Chemistry, Life Science or related discipline is required
  • MS or PhD in Chemistry is preferred
  • 5 to 7 years of work experience in analytical laboratories is required
  • Leading and managing staff personnel is required
  • A working knowledge and understanding of basic chemistry and analytical instrumentation technologies is required
  • Experience executing analytical method development and method validation is required
  • Experience working in a pharmaceutical GMP manufacturing environment is preferred
  • Work experience with radioactive materials is preferred
  • Must be highly organized and able to work under pressure
  • Excellent written and oral communication skills

Benefits

  • Competitive Salary
  • Annual Performance Bonus
  • 401K w/ 3% match
  • Health, Dental, Vision Insurance
  • Optional Life, STD and LTD Insurance
  • Vacation / PTO
  • 10 Paid Holidays
  • Work / Life Balance
  • Great Culture - Uniquely Better!


Isotopia USA

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