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Quality Control Director Location: US-IN-Indianapolis Email this job to a friend
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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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