What are the responsibilities and job description for the Environmental Monitoring - QC Analyst III position at Astrix?
QC Analyst III – Environmental Monitoring (EM)
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
Education
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.
- 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.
- 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.
- 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.
Education
- Bachelor's Degree in Biology, Microbiology, Life Sciences, or a related scientific discipline preferred.
- 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. We look forward to a conversation to learn more about you!***
Salary : $70,000 - $84,000