Job Title: QC Environmental Monitoring Specialist
Location: Exton, Pa
Type: 6-month Contract to Hire  
Schedule: Monday - Friday 8A-5P
 
Overview: 
Our Client a cell and gene therapy company in Exton, PA, is looking for a QC Environmental Monitoring Specialist! You'll be responsible for environmental monitoring in cleanrooms, supporting aseptic manufacturing, and ensuring product quality.
 
Responsibilities: Conduct viable and non-viable environmental monitoring in clean rooms (air, surface, personnel, particulate). Verify batch records for critical aseptic manufacturing steps. Perform Growth Promotion testing on prepared media. Direct Sterile Media Fill Trials and conduct support testing. Maintain QC laboratory housekeeping. Assist in daily QC operations. Author/revise QC SOPs to ensure compliance. Respond promptly to Out of Specification (OOS) results and notify supervisors. Coordinate with Operations (Manufacturing, QA, Facilities) to meet objectives. Use analytical equipment to support product quality. Train employees as needed. Complete thorough Manufacturing Investigation Reports (MIRs) to identify root causes, assess impact, and implement corrective actions. Requirements: Bachelor of Science in a scientific discipline. Knowledge of cGMP and industry standards. Experience in biologics/pharmaceuticals, especially in aseptic processing and mammalian cell culture. Familiarity with basic lab equipment (microscopes, pH meters, incubators).   #M3

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.