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QC Specialist I

Job Description:

SpectronRx has a great opportunity for a  QC Specialist at our South Bend, Indiana facility. You will be responsible for the following activities as part of a dynamic and awesome Quality Control team.

 

Duties and responsibilities include:

  • Performing chemistry manipulations for QC and other responsibilities in a GMP      environment supporting manufacturing schedules.
  • Assist analytical methods and procedures for QC testing of GMP manufactured      radiopharmaceutical products.
  • Gain knowledge by participating in the scheduled preventative maintenance of      instrumentation. 
  • Participate in validation of QC methods and procedures for radiopharmaceutical      products.
  • Adhere to radiation standards and policies. 
  • Gain knowledge by participating in the facility intake of radioisotopes.
  • Ensure regulatory compliance of testing and protocols within quality control operations.
  • Assist with facility driven continuous process improvement projects.
  • Prepare and submit required reports in a timely manner.
  • Assist with the preparation of regulatory submissions.
  • Gain knowledge by participating in the outgoing DOT governed materials. 
  • Support deviation reports, OOS, root cause investigations, and CAPA.
  • Uphold general staff responsibilities for lab cleaning, supplies, and      maintenance.

*The above represent the minimum job expectations and are subject to change.

 

Qualified applicants will have: 

  • A Bachelor’s Degree in Biology, Chemistry, or a related field. An Associates’ Degree in these areas, along with a minimum of 3 years of related Quality experience in a pharmaceutical manufacturing environment 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.
  • 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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