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 seeks a Senior QC Technician with 5+ years in Microbiology, specializing in Sterility Assurance (bioburden testing, sterility dose audits). You will work under the Microbiology Lab Supervisor to perform sterile and non-sterile testing, maintain compliance, and contribute to method validations.

The role requires a Bachelor's in science, ISO 13485/21 CFR 820 familiarity, and strong communication; hours are 40 per week on first shift; contract in W2.

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.
• Proactively identify compliance issues and verify alignment with internal and external standards and policies.
• Notify and work closely with functional management when OOS occurs.
• Maintain a positive and cooperative team dynamic.
• May assist in the design and implementation of new laboratory equipment.
• Other duties as assigned.
• Support training initiatives and training of new associates

Skills

Sterility Assurance

Bioburden Testing

Sterility Dose Audits

Sterile Technique

Bacterial Endotoxins Test

Team Player

Quick Learner

Excellent Communicator

Education

Bachelor's degree in Microbiology or Biology

Job description

Millenniumsoft in San Diego, CA seeks a Senior QC Technician with 5+ years in Microbiology, specializing in Sterility Assurance (bioburden testing, sterility dose audits). You will work under the Microbiology Lab Supervisor to perform sterile and non-sterile testing, maintain compliance, and contribute to method validations.

The role requires a Bachelor's in science, ISO 13485/21 CFR 820 familiarity, and strong communication; hours are 40 per week on first shift; contract in W2.