JOB REQUIREMENTS: SHINE Technologies is immediately seeking a QC
Microbiologist who will have primary focus on performing routine
microbiological benchwork and environmental sampling of multiple
manufacturing cleanroom spaces. This position will also help to ensure
all QC microbiological equipment remains in a state of validation and
calibration and will support the production of Lutetium-177 by
performing the daily responsibilities within the QC microbiology
laboratory, sterility suite, and manufacturing cleanrooms. This role
will also perform a variety of data workup, review, analysis, and
trending as assigned. This new position will transition to 4 10-hour
shifts after completing 3 months of 1st shift training (8 hours
Monday-Friday) Shift: Tuesday - Friday 6:00am - 4:00pm The base salary
range for this position is \$30/hour-\$38/hour plus a comprehensive
compensation package. Our salary ranges are determined by role, level,
and location. Duties and Responsibilities: Specific duties and
responsibilities of the QC Microbiologist include, but are not limited
to: Evaluate and report the microbiological quality of finished goods
and ensure compliance with established specifications while maintaining
compliance to approved methods. 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 operate 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. ***** OTHER EXPERIENCE AND QUALIFICATIONS: 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 for success. Strong experience in
attention-to-detail and following specific written and oral
instructions. Competency in understanding and a willingness to learn a
variety of mathematical analyses. A self-directed, laboratory-focused
mindset with a desire to achieve timely results. A investigative mindset
is preferred. ***** APPLICATION INSTRUCTIONS: Apply Online:
https://recruiting.paylocity.com/recruiting/jobs/Apply/3145747/SHINE-Technologies-LLC/QC-Microbiologist