Quality Control Technician

About the role

The position of QC Technician II is within our Toxicology Business Unit located in Pomona, CA. This role supports quality control functions within our Drugs of Abuse test manufacturing facility. The position focuses on performing in-process and finished product QC testing, and documenting results to ensure product quality and functionality.

Responsibilities

• Perform and document incoming, in-process, and final QC testing of in-vitro diagnostic devices to meet compliance requirements (ISO, FDA, and international regulations)
• Ensure timely release of products
• Maintain accurate records and documentation of test results
• Identify product defects through familiarity with all product aspects
• Use Agile to issue quality incidents, perform root cause investigations, and write reports
• Carry out validation studies and analyses for new or existing products and features
• Prepare adulteration controls and Drugs of Abuse (DOA) controls as needed
• Operate laboratory equipment including analytical balance, optical comparator, vacuum chamber, calipers, gauges, and related tools
• Maintain cleanliness and organization of the QC lab
• Cross-train on QC lab processes and train new staff as needed
• Troubleshoot and resolve process-related issues
• Assist the Head of QC with necessary tasks
• Ensure compliance with established business policies and safe laboratory practices
• Demonstrate awareness of quality consequences related to improper job performance
• Build productive relationships with internal and external stakeholders
• Perform additional duties as assigned based on business needs

Qualifications

• High school diploma required
• 2–5 years of laboratory experience
• Experience working in a GMP environment
• Ability to follow detailed instructions and maintain accurate records
• Good written and verbal communication skills
• Intermediate knowledge of lab equipment and their operation
• Intermediate knowledge of MS Office and manufacturing systems

Preferred Qualifications

• Experience working with semi-automated equipment
• Experience in medical device manufacturing
• Knowledge of regulatory standards (FDA, ISO, OSHA, etc.)
• Strong ability to prioritize multiple tasks with attention to detail

Core Competencies

• Communication
• Attention to detail
• Teamwork
• Results-driven mindset