Senior Microbiology QC Specialist: Sterility & LAL Testing

Indotronix Avani Group; San Diego (CA); On-site; USD 34,000 - 44,000; Full time

Job summary

Indotronix Avani Group is seeking a qualified professional in San Diego, CA, to perform sterility, LAL, and bioburden testing with ISO 13485 compliance. The role includes environmental monitoring, media preparation, and data trending, ensuring timely test turnaround and adherence to QMS procedures.

The ideal candidate holds a 5+ year track record in microbiology, with a strong understanding of ISO 13485 and 21 CFR 820 standards. This is a W2 hourly pay role with first-shift preferred.

Qualifications

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

Responsibilities

• Responsible for sterility testing (SDAs and BI, if applicable), non-sterile bioburden testing and particulate testing while maintaining a sterile field.
• Responsible for LAL testing and associated validations/revalidations.
• Responsible for supporting training and testing and ensuring turnaround times are met.
• Environmental monitoring of the laboratory, controlled areas, and lab spaces as applicable.
• Preparing media for testing, quality checks, and sterilization of testing equipment.
• Metrics, gathering and trending of test data.
• Review QMS documents and procedures prior to release or update as required.

Skills

Sterility testing

LAL testing

Environmental monitoring

Data analysis

Education

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

Job description

Indotronix Avani Group is seeking a qualified professional in San Diego, CA, to perform sterility, LAL, and bioburden testing with ISO 13485 compliance. The role includes environmental monitoring, media preparation, and data trending, ensuring timely test turnaround and adherence to QMS procedures.

The ideal candidate holds a 5+ year track record in microbiology, with a strong understanding of ISO 13485 and 21 CFR 820 standards. This is a W2 hourly pay role with first-shift preferred.