Quality Control Analyst

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SHINE Technologies is seeking a Quality Control Analyst I who will have primary focus on performing laboratory testing and benchwork to support the cGMP production of lutetium‑177 by setting up and executing daily testing of final API product and raw materials. The Quality Control Analyst also ensures all QC analytical equipment remains in a state of validation and calibration. This role will also perform data workup of results generated by themselves or others and assist with reviewing data as assigned.

The base salary range for this position is $25.00 - $35.00 per hour plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location.

• Perform laboratory analysis, evaluate, and report the quality of intermediate and finished product to ensure compliance with established specifications.
• Use different analytical instrumentation to generate results of a variety of sample types.
• 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.

• Minimum: 2-4 years of experience in a cGMP/GLP laboratory with experience operating analytical instrumentation following approved methods.
• 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 strong experience in attention‑to‑detail and following specific written instructions.
• Competency in understanding and a willingness to learn a variety of mathematical analyses.
• A self‑directed, laboratory‑focused mindset with a desire to achieve timely results.

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Mid‑Senior level

Full‑time

Quality Assurance

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