Lab Technician

TechDigital Group; San Diego (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

TechDigital Group is seeking a Sr. QC Technician to support microbiology laboratory operations in San Diego. You will perform sterility and LAL testing, monitor environments, and ensure QA standards are met.

Responsibilities include training support, data trending, QMS reviews, and collaboration with management on OOS issues. A strong candidate holds a Microbiology/Biology degree with 5+ years of experience.

Qualifications

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

Responsibilities

• Perform sterility testing (SDAs and BI) maintaining a sterile field.
• Conduct LAL testing and related validations/revalidations.
• Support training activities and ensure timely turnaround.
• Environmental monitoring of the lab and controlled areas.
• Prepare media, run quality checks, and sterilize testing equipment.
• Collect, trend, and review test data.
• Review QMS documents prior to release or update.
• Identify compliance issues and verify alignment with standards.
• Notify management on out-of-spec events (OOS).
• Assist in design/implementation of new lab equipment.
• Support training of new associates and other duties as assigned.

Skills

Sterility testing

LAL testing

Environmental monitoring

Data analysis

Documentation

Training support

Team collaboration

Education

Bachelor's degree in Microbiology or Biology

Job description

JOB DESCRIPTION

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:

• 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

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