QC Microbiology Technician - Urgent Need

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

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
• Total Hours/week : 40.00
• 1st Shift :
• Client : Medical Devices Company
• Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)
• 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.