Quality Control Microbiology Technician
STAQ Pharma Inc•Columbus, OH
•$0 - $26
About The Position
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.
Requirements
- 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.
- Proficient in using Microsoft Word, Excel, PowerPoint, Outlook.
- Familiarity with 21 CFR Part 11/210/211
Nice To Haves
- Previous pharmaceutical experience.
- Experience in microbiology or quality control preferred.
- Experience in a cGMP or cleanroom setting preferred.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
