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QC Microbiologist
| Company | SHINE Technologies |
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| Location | Rockford, IL, USA |
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| Salary | $30 – $38 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Mid Level |
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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 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.
Responsibilities
- 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.
Preferred Qualifications
- 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.
