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Job Summary:

Quality Control Microbiology Technician 1 will provide clean room support for batch production and ensuring procedure adherence during filling of product. Utilize appropriate controlled documents and assist in quality control deviations/investigations.

Responsibilities:

• Ensure clean rooms and associated areas meet the required cleanliness standards as per company procedures.
• Adhere to strict gowning and personal hygiene practices to prevent contamination and maintain integrity of the clean room environment.
  • Perform gowning qualification training for individuals from all departments who must enter ISO 7 classified areas.
• Monitor and maintain clean room equipment such as viable and non-viable samplers to ensure optimal performance and compliance with established standards.
  • Perform and lead routine environmental monitoring activity in ISO 7 Classified Areas
• Work with production to resolve Quality issues and ensure documentation is complete.
• Perform routine and non-routine viable, non-viable and surface environmental monitoring in all classified areas of the facility.
• Incubation and enumeration of samples related to environmental monitoring processes.
  • Train new personnel on enumeration activities
• Evaluate organisms by colony morphology and perform subculturing.
  • Train new personnel on colony morphology assessment and subculturing activities.
• Perform and/or verify gram stain testing morphology results.
• Continuous improvement activities for environmental monitoring program.
• Provide quality control and microbiology support for operations.
• Collect, submit and manage microbiological samples to third party testing laboratories.
• Assist with QC Microbiologists (and other investigators) with investigations as they relate to environmental monitoring or other quality control deviations.
• Assist QC Microbiologists with data trending and data reporting as they relate to environmental monitoring or other data-generating processes.
• Perform routine testing or cleaning associated with the BioSafety Cabinet.
  • Lead and train new personnel on the cleaning procedures and testing procedures carried out in the BioSafety Cabinet
• Assist in process, procedural, equipment issues via experimentation or revision of procedures.
• Other duties as assigned.

Required Skills/Abilities: (examples)

• Experience with cGMP aseptic manufacturing environment.
• Strong attention to detail.
• Comfortable in a fast-paced, small company environment and able to adjust workload based upon changing priorities.
• Preferred previous pharmaceutical experience.
• Proficient in using Microsoft Word, Excel, PowerPoint, Outlook.
• Familiarity with 21 CFR Part 11/210/211

Education and Experience:

• Associate or Bachelor’s degree in Microbiology, Biology, or related life sciences.
• 0–2 years of experience in microbiology or quality control preferred.
• Experience in a cGMP or cleanroom setting preferred.

Physical Requirements:

• Prolonged periods of sitting at a desk or laboratory bench and working on a computer.
• Must be able to lift up to 15 pounds at times.