Quality Control Technician, Microbiology

As an Quality Control Technician, Microbiology, you will be an important member of the Quality Control team, supporting microbiology testing, environmental and utility monitoring, sample management, and laboratory operations. In this role, you will help ensure accurate, compliant testing and documentation while supporting sterile manufacturing operations in a cGMP environment.

Your

• ◆Perform routine and non-routine environmental monitoring, including viable/non-viable air, surface, personnel, and manufacturing area sampling.
• ◆Monitor and test critical utilities, including WFI, USP Water, Pure Steam, and Clean Compressed Air.
• ◆Conduct microbiology testing of raw materials, in-process materials, finished products, and stability samples, including endotoxin, bioburden, mycoplasma, and sterility testing.
• ◆Perform microbiology support activities including media growth promotion, gram staining, microbial identification, and other laboratory testing.
• ◆Provide production support through production fills and aseptic process simulations while maintaining sterile gowning qualifications.
• ◆Support quality investigations and documentation, including OOS/OOT investigations, environmental and facility investigations, deviations, Certificates of Analysis, SOPs, and controlled documents.
• ◆Assist with method development, validation, qualification, method transfers, and analytical studies, as well as equipment validation, calibration, and maintenance.
• ◆Maintain laboratory operations, inventory, equipment checks, cleanliness, and accurate data while ensuring compliance with cGMP, safety, environmental, and regulatory requirements.

• ✓Education: High School Diploma/GED with 5 years of relevant experience, or a Bachelor’s degree in Microbiology, Biological Sciences, Pharmaceutical Sciences, or a closely related field.
• ✓Experience: Experience in a laboratory or technical environment with microbiology responsibilities.
• ✓Top 2 skills: Strong technical skills in microbiology, including aseptic technique, combined with strong documentation, communication, and organizational skills.

• ✓Experience working in a cGMP-regulated environment.
• ✓Experience with sterility testing, mycoplasma, environmental monitoring, and water testing.
• ✓Knowledge of pharmaceutical cGMP

and applicable FDA, USDA, VICH, and EU regulations related to QC activities.

• ✓Experience with analytical method development, validation, qualification, or method transfers.
• ✓Experience using instrument software to obtain and manage laboratory results.
• ✓Strong problem-solving and attention-to-detail skills with the ability to work effectively in a cross-functional team environment.
• ✓Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
• ✓Ability to support a physically demanding laboratory environment, including extended periods on your feet and moving heavy materials or supplies.