Location:

Dayton, OH Schedule:

Monday-Friday | 8:00 AM•5

PM Employment Type:

Perm Hire, Full-Time Salary:

$70,000•$84,000 + Annual Bonus Relocation Assistance Available About the Opportunity A top-performing pharmaceutical manufacturer recognized for its exceptional workplace culture, is seeking a QC Analyst III•Environmental Monitoring (EM) to join its Quality Control team. This is a unique opportunity to work in a sterile manufacturing environment where you'll have a direct impact on product quality, patient safety, and operational excellence while partnering with a highly collaborative and supportive team! Key Responsibilities Environmental Monitoring Perform routine, batch-related, and quarterly environmental monitoring in aseptic, classified, and controlled manufacturing areas. Collect environmental monitoring samples in cleanroom environments. Support sterile manufacturing operations through production observations and cleanroom walkthroughs. Monitor compliance with aseptic techniques and contamination control strategies. Utilities Monitoring & Testing Perform utilities sampling and testing of: Water for Injection (WFI) Purified Water (PW) Potable/City Water Compressed Air Nitrogen and other process gases Conduct microbiological testing including: Endotoxin (Required) Bioburden (Required) TOC (Preferred) Conductivity (Preferred) Enumerate organisms from environmental and utility samples. Quality Systems & Documentation Author, revise, and maintain: SOPs Risk Assessments Change Controls Protocols Technical Reports Support investigations, deviations, and corrective actions. Review technical documentation from internal stakeholders. Maintain documentation in accordance with GMP requirements. Training & Technical Leadership Train manufacturing and environmental monitoring personnel Support gowning qualifications and annual requalification activities. Mentor junior team members and serve as a technical resource within the department. Represent the department during meetings, audits, and cross-functional initiatives. Required Qualifications Education Bachelor's Degree in Biology, Microbiology, Life Sciences, or a related scientific discipline preferred. Required Experience 5+ years of pharmaceutical microbiology, QC, or Environmental Monitoring experience. Experience supporting sterile manufacturing operations. Environmental Monitoring (EM) and cleanroom sampling experience. Aseptic gowning and sterile gowning qualification experience. Utilities sampling and testing experience.

Required:

Endotoxin and Bioburden testing. Experience with water systems (WFI, Purified Water, Potable Water) and compressed gases (air and nitrogen). •This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. 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Environmental Monitoring - QC Analyst III