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Job summary
The Quality control lead will oversee the day-to-day quality control activities at Invicro's New Haven site by managing the QC team, overseeing inventory, ensuring equipment calibration and qualification is performed on time and according to written procedures and perform quality control testing under GMP condition. This role will report to the director of radiochemistry.
Major responsibilities
- Manage Chemistry Quality Control team members, daily operations of the quality control team and responsible for delegating work to assigned staff and establishing workflow standards/expectations. Perform PET and SPECT radiotracer quality analysis in full compliance with applicable regulations and internal requirements
- Actively support and perform maintenance of analytical equipment
- Oversee and ensure the quality control program is proceeding efficiently within the framework of regulatory compliance and operating within with strict adherence to phase-appropriate cGMP standards, environmental health and safety, good working practices and related guidelines...
Qualification
- Strongly preferred PhD in Chemistry or Master's Degree in engineering or physical sciences.
- 5-10 years of analytical chemistry experience
- 3-5 years of people management experience
- 1-3 years of experience working in a cGMP environment
- 1-3 years of experience working under aseptic conditions for the preparation of sterile product(s)
- Demonstrated proficiency in the cGMP operation and extensive experience with conventional analytical instrumentation.
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looks like Blogger doesn't work with anonymous comments from Chrome browsers at the moment - works in Microsoft Edge, or from Chrome with a Blogger account - sorry! CJ 3/21/20