QC Microbiologist

SHINE Technologies; Janesville (WI); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a QC Microbiologist to join their team in Janesville, WI. This role focuses on performing microbiological testing, ensuring compliance with safety standards, and supporting the production of Lutetium-177. Candidates should hold a BS in Microbiology with relevant laboratory experience. The position offers a competitive hourly wage and requires attention to detail along with a hands-on approach to technology.

Qualifications

• 2-4 years in a cGMP/GLP laboratory.
• Experience in Pharmaceuticals, Medical Devices, or Radiopharmaceuticals is preferred.
• Knowledge of regulatory standards (cGMP, ICH).

Responsibilities

• Evaluate and report microbiological quality of finished goods.
• Perform environmental monitoring and sterility testing.
• Comply with cGMP, GLP, and GDocP standards.

Skills

Attention to detail

Analytical skills

Investigative mindset

Education

BS in Microbiology

Job description

Join to apply for the QC Microbiologist role at SHINE Technologies

Job Requirements

SHINE Technologies is immediately seeking a QC Microbiologist who will focus on performing routine microbiological benchwork and environmental sampling of multiple manufacturing cleanroom spaces. This position also involves ensuring all QC microbiological equipment remains validated and calibrated, supporting the production of Lutetium-177 by performing daily responsibilities within the QC microbiology laboratory, sterility suite, and manufacturing cleanrooms. The role includes data workup, review, analysis, and trending as assigned. After completing 3 months of 1st shift training (8 hours, Monday-Friday), the position will transition to 4 10-hour shifts: Tuesday - Friday, 6:00 am - 4:00 pm. The base salary range is $30/hour - $38/hour plus a comprehensive benefits package.

Responsibilities

• Evaluate and report the microbiological quality of finished goods, ensuring compliance with specifications and approved methods.
• Perform daily/weekly environmental monitoring testing (cleanroom and water testing), sterility, and endotoxin testing of final products for release.
• Review and execute microbiological tests/procedures.
• Set up and operate microbiological lab equipment.
• Participate in investigations of Out of Specification results and environmental excursions.
• Sample raw materials, perform in-house testing, and coordinate external testing.
• Ensure preventative maintenance and calibration of microbiological lab equipment.
• Perform data entry of environmental monitoring results.
• Maintain a clean and compliant QC laboratory environment.
• Comply with cGMP, GLP, and GDocP standards.
• Other duties as assigned.

Qualifications

Minimum: 2-4 years in a cGMP/GLP laboratory. Preferred: BS in Microbiology with 0-2 years experience in Pharmaceuticals, Medical Devices, or Radiopharmaceuticals, with cleanroom experience and knowledge of radiation pharmaceuticals. Ability to conduct analytical assays, understanding of cGMP, ICH, SP, and other regulations. Willingness to be "hands-on" with new technology, attention to detail, and ability to follow written and oral instructions. Competency in mathematical analyses, self-directed, and investigative mindset preferred.

Application Instructions

Apply online at: https://recruiting.paylocity.com/recruiting/jobs/Apply/3145747/SHINE-Technologies-LLC/QC-Microbiologist

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Research, Analyst, and Information Technology
• Industry: Pharmaceutical Manufacturing

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