Senior Lab Technician – Microbiology & Sterility Assurance

Lancesoft; San Diego (CA); On-site; USD 65,000 - 85,000; Full time

Job summary

Reporting to the Microbiology Lab Supervisor, the Sr. QC Technician supports activities within the Microbiology Lab.

The role performs studies and microbiology testing per work instructions, procedures, protocols, and standards, maintaining accuracy, records, and compliance with internal QA procedures and external standards. The position requires a Bachelor's in science (Microbiology/ Biology) with 5+ years in a Sterility Assurance Microbiology laboratory, plus knowledge of ISO 13485 and 21 CFR

Qualifications

• Bachelor's degree in science (Microbiology/ Biology) with 5+ years in a Sterility Assurance Microbiology lab.
• Familiarity with ISO 13485 and 21 CFR 820.
• Strong teamwork and communication skills.

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.
• Support 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

Sterile Technique

Bacterial Endotoxins Test

Education

Bachelor's degree in Microbiology or Biology

Job description

Reporting to the Microbiology Lab Supervisor, the Sr. QC Technician supports activities within the Microbiology Lab.

The role performs studies and microbiology testing per work instructions, procedures, protocols, and standards, maintaining accuracy, records, and compliance with internal QA procedures and external standards. The position requires a Bachelor's in science (Microbiology/ Biology) with 5+ years in a Sterility Assurance Microbiology laboratory, plus knowledge of ISO 13485 and 21 CFR