Job Description

Overview

Selution, in partnership with Cordis, specializes in the development of groundbreaking technology and commercialization of advanced drug-device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

The Microbiology Technician I supports routine microbiology laboratory and environmental monitoring activities for the Irvine manufacturing site. This position performs bacterial endotoxin testing, environmental sampling, laboratory documentation, equipment and supply management, and other microbiology laboratory activities in accordance with applicable procedures, ISO 13485 requirements, cGMP, GDP, and laboratory safety requirements.

The role works cross-functionally to support cleanroom monitoring and related projects while helping maintain the microbiology laboratory in a compliant, organized, and inspection-ready state.

Key Responsibilities

Microbiology Testing & Environmental Monitoring

• Perform Lot Release Bacterial Endotoxin Testing (BET) and testing associated with applicable protocols.
• Perform environmental sampling within a Class 8 cleanroom.
• Apply appropriate aseptic and micropipette techniques while performing laboratory activities.
• Support cleanroom monitoring activities and other microbiology-related projects.
• Assist with equipment qualifications and test method qualifications.

Quality & Regulatory Compliance

• Comply with all applicable Microbiology procedures and relevant site-wide procedures under ISO 13485.
• Comply with all laboratory safety requirements and procedures.
• Perform assigned activities in accordance with applicable cGMP and Good Documentation Practices (GDP).
• Maintain accurate and complete laboratory documentation in support of quality and regulatory requirements.

Data & Documentation Management

• Review and enter environmental monitoring data.
• Maintain laboratory equipment records and related documentation.
• Perform general administrative activities, including scanning and filing.
• Ensure laboratory records are organized, accurate, and maintained appropriately.

Laboratory Operations & Inventory

• Perform routine microbiology laboratory sustaining activities, including opening and closing the laboratory.
• Handle biohazard waste in accordance with applicable procedures.
• Maintain media, laboratory instruments, and supplies required for routine laboratory operations.
• Monitor and maintain laboratory supply inventory.
• Generate purchase orders and coordinate ordering of laboratory supplies.
• Receive materials and supplies supporting laboratory operations.

Cross-Functional Support

• Work collaboratively within cross-functional teams to support cleanroom environmental monitoring and related projects.
• Communicate effectively with internal stakeholders regarding laboratory activities, testing, documentation, and operational needs.

Qualifications

Required Qualifications:

• High school diploma or equivalent.
• Proficient computer skills, including Microsoft Word and Excel.
• Knowledge of aseptic technique.
• Knowledge of micropipette techniques.
• Working knowledge of cGMP and GDP requirements.
• Strong organizational skills.
• Strong written and verbal communication skills.
• Critical-thinking skills sufficient to support laboratory investigations.
• Ability to work efficiently in a fast-paced environment while maintaining a high level of accuracy and attention to detail.
• Availability to work the day shift (~ 8AM to 4:30PM), with some weekend work; possibly 4-6hrs, 1 to 2 times a month

Preferred Qualifications:

• 1+ years of experience within the medical device industry or a similar regulated environment.
• Experience with cleanroom environmental monitoring.
• Microbial culturing experience.
• Experience using a Laboratory Information Management System (LIMS).

Pay / Compensation

The expected pre-tax pay rate for this position is $21.95–$27.50 hourly. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge, and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

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