Quality Control Microbiology Technician

STAQ Pharma; Columbus (OH); On-site; USD 52,000 - 68,000; Full time

Job summary

STAQ Pharma in Columbus, OH, seeks a Quality Control Microbiology Technician 1 to support clean room operations during batch production and ensure adherence to procedures. You will assist in deviations/investigations and engage in environmental monitoring activities in ISO 7 areas.

The role requires cGMP experience, strong attention to detail, and the ability to work in a fast-paced, small company environment. Proficiency in MS Office and familiar with 21 CFR Part 11 is preferred.

Qualifications

• Associate or Bachelor's degree in Microbiology, Biology, or related life sciences.
• Experience in microbiology or quality control preferred.
• Experience in a cGMP or cleanroom setting preferred.

Responsibilities

• Ensure clean rooms meet required cleanliness standards.
• Adhere to gowning and personal hygiene practices to prevent contamination.
• Perform environmental monitoring in ISO 7 Classified Areas.
• Support QC investigations and data trending related to environmental monitoring.
• Train new personnel on enumeration and colony morphology procedures.
• Assist with data reporting and documentation in investigations.

Skills

cGMP aseptic

Attention to detail

Fast-paced environment

Pharmaceutical experience

MS Office suite

21 CFR Part 11 familiarity

Education

Associate or Bachelor's degree in Microbiology

Quality control experience preferred

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

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

• 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.
• 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.

The application window for this position is anticipated to be open at least 25 days.