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Production / QC Chemist

Job Description:

SpectronRx has a great opportunity for a Production/Quality Control (QC) Chemist at our South Bend, Indiana facility. You will be responsible for process manufacturing of radiopharmaceutical products, preparation of production materials, supplies, general production equipment maintenance and quality control of products as part of a dynamic and awesome Production and Quality Control team.

 

Duties and responsibilities include:

  • Carries out production responsibilities to meet manufacturing schedules.
  • Performs chemistry manipulations for production and QC in a GMP environment.
  • Ensure regulatory compliance of production and QC protocols within the manufacturing operations.
  • Analytical methods and procedures for QC testing of GMP manufactured radiopharmaceutical products.
  • Optimize and validate QC methods and procedures for radiopharmaceutical products.
  • Assist with creating SOP’s for use in production and QC.
  • Prepare and submit required reports.
  • Assist with the preparation of regulatory submissions.
  • Supporting and executing deviation reports, OOS, root cause investigations, and CAPA.
  • Assist with general lab cleaning, supplies and maintenance.

 

Qualified applicants will have: 

  • A Bachelor’s Degree in Chemistry, Biochemistry, Chemical Engineering or a related field. An Associates’ Degree in these areas, along with a minimum of 3 years of related experience in a pharmaceutical manufacturing environment (with preference to radiopharmaceuticals) may be considered.
  • Requires a minimum of 2 years of prior experience in pharmaceuticals, preferably in a quality or production position. Prior experience in a radiopharmaceutical environment a plus.
  • Prior experience with HPLC, Gas Chromatography (GC) and/or ICP-MS.
  • Excellent communication, analytical, computer/pc and technical writing skills.
  • The ability to handle responsibilities in a fast paced manufacturing environment.
  • Great attention to detail, and excellent communication skills.
  • Demonstrated ability to work as part of a team. 

 

We offer a competitive compensation & benefits package. Join a company on the move!

Must be authorized to work in the U.S. Please send your CV to HR@spectronrx.com.

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