Quality Control Lead

at SHINE Medical Technologies
Location Middleton, Wisconsin
Date Posted September 15, 2020
Category Biotechnology
Job Type Full-time
Address 8123 Forsythia St, Ste 140

Description

SHINE is seeking additional quality staff in a newly formed Quality Department supporting the production of lutetium-177 for the treatment of cancer. This individual will set up and run daily operations in the Quality Control Lab, set up and run the Environmental Monitoring Lab for, qualify equipment, and draft and validate SOPs. Work will begin on product for clinical trials, but will in a few years transition to a new site for production to support commercial drug sales. Eventually, this individual will develop analytical, sterility and endotoxin testing procedures for the final radiopharmaceutical API.  In addition, this individual will support the QA department by assisting with Document Control. This is a newly created position with potential for significant growth.

Responsibilities and Duties

  • Ability to draft microbiological-related SOPs in support of monitoring a GMP clean room environment.
  • Help with the validation of the clean rooms by conducting environmental monitoring.
  • Set up Quality Control lab equipment (analytical and micro) at the clinical manufacturing site and eventually at the commercial site.
  • Conduct routine environmental monitoring of the clean rooms and trending of all data.
  • Execute microbiological assays and work with contract laboratory for additional microbiological testing requirements.
  • Learn and execute analytical testing requirements for final API product.
  • Sample raw materials for testing per the material specifications and coordinate testing with contract laboratory.
  • Release of raw materials upon completion of appropriate testing by contract laboratory and review by QA.
  • Document Control support for QA, to include drafting and reviewing SOPs and other documents, organizing paper files such as specification and equipment files.
  • Ensure preventative maintenance and calibration activities for micro lab equipment are carried out to schedule.
  • Summarize data in support of management review meetings.

Qualifications

  • BS in scientific discipline.
  • Previous experience working in a GMP environment (5-6 years) conducting environmental monitoring for clean rooms preferred.
  • Previous knowledge of clean room validation preferred.
  • Willingness to be “hands on” and understand new technology required.
  • Ability to write procedures and review documentation required.

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