Senior QC Microbiology Technician: Sterility & Bioburden

Millenniumsoft; San Diego (CA); On-site; USD 37,000 - 53,000; Full time

Job summary

Millenniumsoft in San Diego, CA is seeking a QC Microbiology Technician with 5+ years of Sterility Assurance experience to support the Microbiology Lab. The role focuses on sterility testing, bioburden assessments, LAL validations, and maintaining strict quality records.

Responsibilities include environmental monitoring, media preparation, and timely testing across accredited procedures while ensuring compliance with ISO 13485 and 21 CFR 820 standards.

Qualifications

• Bachelor's degree in science (Microbiology or Biology related) with 5+ years relevant experience in Sterility Assurance.
• Understanding of ISO 13485, 21 CFR 820 and other related standards.

Responsibilities

• Responsible for sterility testing (SDAs and BI) and non-sterile bioburden testing while maintaining a sterile field.
• LAL testing and associated validations/revalidations.
• Environmental monitoring of the laboratory and controlled areas.
• Preparing media for testing and quality checks.

Skills

Sterility Assurance

Bioburden Testing

Sterility Dose Audits

Sterile Technique

Endotoxins Testing

Education

Bachelor's degree in science (Microbiology or Biology related)

Tools

LAL testing equipment

Job description

Millenniumsoft in San Diego, CA is seeking a QC Microbiology Technician with 5+ years of Sterility Assurance experience to support the Microbiology Lab. The role focuses on sterility testing, bioburden assessments, LAL validations, and maintaining strict quality records.

Responsibilities include environmental monitoring, media preparation, and timely testing across accredited procedures while ensuring compliance with ISO 13485 and 21 CFR 820 standards.