QC Analyst

Description

SHINE Technologies is seeking a QC Analyst I whose primary focus will be 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 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.

This new position will transition to 4 10-hour shifts (6:00am-4:00pm Tuesday-Friday) after completing 3 months of 1st shift training (8 hours Monday-Friday)

Duties And Responsibilities

Specific duties and responsibilities include, but are not limited to:

• 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.
  
  

Requirements

• 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 understand new technology required for success.
• 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.
  
  

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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