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Environmental Monitoring - QC Analyst III

Astrix Technology Group -
Wilmington, OH

Quick Apply

Job Details

Full-time
$70,000 - $84,000 a year

Benefits

Relocation assistance

Qualifications

Cleanroom environmental monitoring
Sterile field situational awareness
Microbiology testing
Microbiological water quality analysis
Cleanroom protocols
Manufacturing facility experience
Pharmaceutical company experience
Water systems
Cleanroom experience
Environmental monitoring
Microbiological analysis
Microbiological testing for sterile processing
Pharmaceutical manufacturing facility experience

Full Job Description

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

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. We look forward to a conversation to learn more about you!***

#LI-DH3
INDBH

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Refine Your Search

quality control inspector jobs in wilmington oh

Environmental Monitoring - QC Analyst III

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