Description:
SHINE Technologies is seeking a QC Microbiologist who will support the production of Lutetium-177.
The QC Microbiologist is responsible for performing the daily responsibilities within the QC microbiology laboratory and helping to ensure all QC microbiological equipment remains in a state of validation and calibration.
Duties and Responsibilities:
Specific duties and responsibilities of the QC Microbiologist include, but are not limited to:
Evaluate and report the quality of finished goods and ensure compliance with established specifications.
Perform daily/weekly environmental monitoring testing (cleanroom monitoring, water testing), sterility and endotoxin testing of final product for release.
Review and execute microbiological tests/procedures.
Set up and operation of Quality Control lab equipment (microbiological).
Participate in Out of Specification investigations and Environmental Excursions as needed.
Sample raw materials per the material specifications and perform in-house testing, including growth promotion testing of media.
Coordinate testing and shipping to contract laboratories for external lab testing.
Ensure preventative maintenance and calibration activities for microbiological lab equipment are carried out to schedule.
Perform data entry of environmental monitoring results.
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.
Requirements:
Minimum: 2-4 years of experience in a cGMP/GLP laboratory.
Preferred: BS in Microbiology with 0-2 years of experience in Pharmaceuticals, Medical Device or Radiopharmaceuticals, cleanroom experience and knowledge 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.
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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