Quality Technician
Simtra BioPharma Solutions
Bloomington, INFresher1h agovia LinkedIn
About the Role
The Quality Technician - Environmental Monitoring is an entry-level position within the Quality Assurance Line Operations group. This role involves independent performance of routine sampling and processing of samples to support the Quality department.
Reports to: Quality Line Operations (QALO) Supervisor
Working Hours: Friday, Saturday, Sunday, 7:00 AM - 7:30 PM
Key Responsibilities
- Sample controlled environments per the sampling Master Plan utilizing aseptic technique.
- Document and process samples in a Laboratory Information Management System (LIMS).
- Perform real-time risk assessments of manufacturing areas and processes.
- Maintain data integrity and ensure compliance with company standard operating procedures (SOP’s) and worldwide regulatory requirements.
- Recognize and escalate non-conformances.
Requirements & Tech Stack
- High school diploma or GED.
- Prior experience preferred.
- Computer proficiency in Microsoft Word, Excel, and Outlook.
- Ability to use enterprise software (examples include: D365, Veeva, LabWare).
- Strong communication skills.
Physical / Safety Requirements
- Must be able to gown qualify for Grade C/D area.
- Ability to perform extended periods of standing.
- Must be able to wear applicable Personal Protective Equipment (PPE).
- Duties may require overtime work, including nights, holidays, and weekends.
- Use of hands and fingers to manipulate office and laboratory equipment.
- Must be able to lift 20 lbs.
- Must be able to qualify for 20/25 corrected vision and pass a color blindness test.