Sterility Assurance, Aseptic Process Monitor 2nd Shift
On-site · Sugar Land, Texas, United States
Job Summary
Sterility Assurance, Aseptic Process Monitor supports QA in the clean room during media fills, monitors gown qualification, EM/PM sampling, and aseptic practices; maintains records and assists in sterility investigations while ensuring compliance with cGMP. The role focuses on evaluating environmental/Personnel monitoring data, providing feedback to compounders, and ensuring aseptic technique during media fills. This is a full-time, 2nd-shift position (2:00 PM to 6:30 PM), on-site at Sugar Land, TX, with a set schedule and potential overtime. The successful candidate will work under SOPs and QA/QMS guidelines, participate in environmental monitoring, records maintenance, and regulatory compliance activities.
Required Qualifications
- A High School diploma or equivalent
- Able to successfully complete a drug and background check
- At least 2 years’ experience in Quality Assurance, Microbiology, Sterile Compounding in pharmaceutical manufacturing
- Previous training and experience in environmental monitoring, and sampling
- Thorough understanding of 21CFR Part 211 cGMP requirements for sterile drug products with emphasis on 2004 Guidance for Sterile Drug Products produced by Aseptic Processing
- Strong Microsoft Word and Excel skills
- Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation
- Must be currently authorized to work in the United States on a full-time basis; Quva will not sponsor applicants for work visas
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