Description:
SHINE Technologies is seeking QC Analyst who will support the production of lutetium-177.
This individual will set up and execute daily testing of final API product and raw materials.
The QC Analyst will ensure all QC analytical equipment remains in a state of validation and calibration.
Duties and Responsibilities:
Specific duties and responsibilities of the QC Analyst include, but are not limited to:
Perform analysis, evaluate, and report the quality of finished product and ensure compliance with established specifications.
Sample raw materials per the material specifications and perform in-house testing.
Coordinate testing and shipping to contract laboratories for external lab testing.
Prepare solutions for testing.
Daily set up of Quality Control lab equipment (analytical).
Ensure preventative maintenance and calibration activities for analytical equipment are carried out to schedule.
Ensure QC Laboratory is maintained in a clean and compliant manner.
Comply with Good Manufacturing Practices, Good Laboratory Practices and Good Documentation Practices.
Other duties as assigned by Management.
Requirements:
Minimum: 2-4 years of experience in a cGMP/GLP laboratory with experience operating analytical instrumentation.
Preferred: BS in scientific discipline, analytical chemistry with 0-2 years of experience in Pharmaceuticals, Medical Device or Radiopharmaceuticals, knowledge of HPLC and ICP-MS instrumentation, and previous work related to radiation pharmaceuticals, ability to conduct analytical assays with knowledge of cGMP, ICH, SP and other global compendial regulations and guidance.
Willingness to be “hands on” and understand new technology required.
Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.
S.
Export Controls.
Additionally, applicant’s eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug screen, fingerprinting and criminal background check.
SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success.
Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.
SHINE Technologies is an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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