QC Microbiologist I: Bioburden & Cleanroom Validation

americanregent; Brea (CA); On-site; USD 46,000 - 48,000; Full time

Job summary

American Regent is seeking a quality control professional to perform bioburden, endotoxin, and environmental monitoring in manufacturing environments. You will test raw materials, in-process samples, and finished products while supporting aseptic processes and cGMP documentation.

The ideal candidate holds a BS in Microbiology or a related field, up to 2 years of pharma QC experience, and demonstrates independence, strong organization, and meticulous attention to detail.

Qualifications

• BS in Microbiology or related field; up to 2 years pharma QC experience.
• Ability to work independently and manage multiple tasks.
• Strong attention to detail and documentation.

Responsibilities

• Perform bioburden and endotoxin testing per specs.
• Develop, optimize, and validate microbiological test methods.
• Generate protocols, review data, and write final reports.
• Operate Autoclave and Sterilization-in-Place equipment.
• Support environmental monitoring in cleanrooms Grade C & D.

Skills

Bioburden testing

Endotoxin testing

Microbial enumeration

Gram staining

Aseptic process

Documentation accuracy

Education

Bachelor of Science in Microbiology

Equivalent combination of education and experience

Tools

Autoclave

MS Office

Job description

American Regent is seeking a quality control professional to perform bioburden, endotoxin, and environmental monitoring in manufacturing environments. You will test raw materials, in-process samples, and finished products while supporting aseptic processes and cGMP documentation.

The ideal candidate holds a BS in Microbiology or a related field, up to 2 years of pharma QC experience, and demonstrates independence, strong organization, and meticulous attention to detail.