QC Microbiologist

Description

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: 6:00am - 4:00pm

Tuesday - Friday

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.
  
  

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.
  
  

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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