Lab Technician

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

Manager Notes

Technology Requirements (I.E Programs, systems, etc)

Position : QC Microbiology Technician Req 5 Yrs Exp in Microbiology, specifically in Sterility Assurance

Location : San Diego CA

Duration : 12 Months

Note

Pay Rate - $ 32.50/hr

Hours: M-F 6:30am start or later is preferred

Job Description -

• looking for a Senior Technician with experience in Microbiology, specifically in Sterility Assurance (e.g. Bioburden Testing, Sterility Dose Audit Testing)

Skillset Matrix

Manager Notes

• Technology Requirements (I.E Programs, systems, etc)
• Sterility Assurance Testing (e.g. Bioburden, Sterility Dose Audits)
• Sterile Technique, Bacterial Endotoxins Test
• What does a typical day look like? (daily tasks)
• Preparing for and performing relevant scheduled tests.
• Preferred background/prior work experience?
• 5+ years in Sterility Assurance Microbiology Laboratory setting
• Priority soft skills
• Team Player, Quick Learner, Excellent Communicator

Job Summary

• Reporting to the Microbiology Lab Supervisor, the Sr. QC Technician is responsible for supporting activities within the Microbiology Lab.
• The role performs studies and microbiology testing required by established work instructions, procedures, protocols, and standards.
• The technician must exercise accuracy and attention to detail, maintain accurate records, and ensure compliance with internal Quality Assurance procedures and external standards and regulations.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• 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

Education And Experience

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