Chemist - Quality Control

Role Summary

The Chemist – Quality Control role supports the Radioligand Therapy (IRLT) group in Indianapolis by performing accurate and timely testing of routine and select non-routine radioactive lab samples in compliance with GMP and safety guidelines. The chemist verifies others’ results, participates in analytical investigations, equipment evaluations and qualifications, and contributes to quality system improvement initiatives through defined protocols and procedures.

Responsibilities

• Sample Analysis and Reporting
  • Verify analytical data of other analysts within the lab as requested.
  • Accurately and safely perform analytical test methods or related support activities per procedures or protocols, reviewing and interpreting data for conformance to procedures, standards, and protocols; recognize aberrant data in real time.
  • Perform data entry and review own work for accuracy in accordance with laboratory procedures, standards, and GMP requirements.
  • May perform holistic review of data for release of data from the laboratory.

• Problem Solving
  • Recognize deviations from test methods and procedures and initiate analytical investigations, participating in Root Cause Investigations.
  • Participate, including as lead investigator, in investigations for deviations.
  • Assist in troubleshooting equipment and methods as required.

• Continuous Improvement Initiatives
  • Assist in improving quality systems by creating or revising worksheets and other lab documentation systems.
  • Identify and communicate opportunities for improvement in daily activities.
  • Review SOPs for executable as written.
  • Share technical information and best practices within plant sites or groups.

• Lab Operations
  • Assist with drafting protocols for non-routine testing or validation.
  • Assist in developing equipment qualification protocols.
  • Perform routine equipment calibrations or maintenance.
  • Comply with and assist with implementing safety standards.
  • Notify management as required by procedures or standards.
  • Initiate lab deviations.
  • Train and mentor others; assist with developing training materials.

Qualifications

• Bachelor‚Äôs degree in a science field related to the lab (e.g., chemistry, biochemistry, biology, etc.).
• Preferred 1+ years of experience in a GMP analytical lab.

Skills

• Experience with radioactive materials is a plus.
• Proficiency with LIMS, Empower, Chromeleon, Excel, etc.
• Proficiency with UHPLC, pH meters, ICPMS, Rad detectors, Dose calibrators, and Gamma detectors is a plus.
• Ability to work in a lab environment with PPE and safety considerations.
• Strong math and documentation skills; strong oral and written communication and interpersonal skills.

Education

• Bachelor‚Äôs degree in a science field related to the lab (as above).

Additional Requirements

• Position supports a 4 day, 10 hour shift (Saturday-Wednesday) or (Wednesday-Sunday) with day and night shifts; night shift preferences may be favored.
• Tasks may require repetitive motion and standing for long periods.
• Must be able to lift at least 5 liters of liquid.
• Overtime may be required.