cGMP Quality Control Lab Technician

University of Southern California; California, Los Angeles (MO, CA); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a dedicated cGMP Quality Control Lab Technician to support its microbiological testing and quality assurance efforts. This role is critical in maintaining the integrity of cell and gene therapies, ensuring compliance with stringent cGMP regulations. The technician will be responsible for executing a range of laboratory procedures, developing testing protocols, and training team members. Joining this innovative institution means becoming part of a vibrant community focused on excellence in research and education, where your contributions will directly impact the quality of life through advanced medical solutions.

Qualifications

• Degree in a related scientific field with specialized laboratory experience.
• Strong communication and writing skills, able to work independently and in teams.

Responsibilities

• Execute microbiological testing and validate sterility/microbiology tests.
• Perform environmental monitoring and ensure cGMP room cleanliness.
• Train students and investigators in specialized laboratory techniques.

Skills

Microbiological Testing

Laboratory Procedures

Environmental Monitoring

Communication Skills

Data Management

Education

Bachelor's Degree in a Scientific Field

Tools

Specialized Laboratory Equipment

Job description

cGMP Quality Control Lab Technician
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Keck School of Medicine
Los Angeles, California

The University of Southern California (USC), founded in 1880, is located in the heart of downtown L.A. and is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the "Trojan Family," which is comprised of the faculty, students and staff that make the university what it is.

USC's Keck School of Medicine, Department of Medicine is seeking a specialized microbiological technician to support the cGMP facility and associated laboratories. The technician will execute microbiological testing, develop and validate sterility/microbiology tests, perform environmental monitoring sampling, and collect microbial environmental data to ensure cGMP room cleanliness. They will also perform moderate to complex laboratory procedures related to microbiology, including preparing media formulations, producing microbiological materials, and conducting agar plate testing. The technician will play a critical role in maintaining the quality and safety of cell and gene therapies and other biological products manufactured in the cGMP facility.

Job Accountabilities:

• Execute microbiological testing (endotoxin, mycoplasma, retrovirus detection assays etc.) for in-process, batch release, and stability samples of therapeutic products in accordance with cGMP regulations.
• Develop, optimize, and validate sterility/microbiology tests for specific products.
• Perform environmental monitoring sampling within the cleanroom in accordance with cGMP regulations.
• Collect, review, and monitor microbial environmental data to ensure cGMP room cleanliness and suitability for use.
• Performs moderate to complex specific laboratory procedures, testing etc, utilizing techniques and technology related to specialized scientific field. (e.g. May prepare regular and special media formulations; produce grow or culture microbiological materials; performs Elisa plate testing with consistent high quality test results, etc.)
• Trains investigators and students in specialized laboratory techniques. Provides technical consulting in area of expertise. Assists in protocol or policy development.
• Performs other highly specialized laboratory tests as appropriate.
• Complies with any quality control policies and procedures and maintains required documentation.
• Maintains a safe environment in accordance with standards, policies and safety regulations. Ensures compliance with infection control policies.
• Handles and disposes of hazardous and non-hazardous materials in accordance with safety protocols.
• Maintains and calibrates laboratory equipment. Performs or arranges for basic repairs. May alter equipment to meet experiment requirements. Makes recommendations for equipment acquisitions.
• Creates and maintains databases and/or spreadsheets to manage and process information or data.
• May supervise unit employees and/or student workers as assigned. Trains and provides additional instruction as required. Schedules, assigns, and prioritizes workloads on a daily basis. Sets appropriate goals and deadlines. Ensures timely completion of unit's work. Assigns and oversees progress of special projects for staff and student workers.
• Assists in budget preparation by gathering historical data in a limited area, such as materials and supplies or salaries. Tracks and monitors assigned budget expenditures and reports on variances.
• Organizes and maintains supplies. Monitors inventory levels, maintains records of supplies and equipment, and prepares purchase orders as needed. Provides advice on equipment upgrades and acquisitions.
• Keeps informed of developments in field. Reads journals and other relevant publications, attends professional association meetings and seminars as appropriate.
• Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.

Successful Candidates Must Demonstrate:

• Degree in directly related specialized scientific field. Previous specialized laboratory experience, knowledgeable in use of specialized laboratory equipment. Working knowledge of lab procedures, techniques and testing related to specialized scientific field. Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.

Fixed term: 3 years

The hourly range for this position is $36.05 - $37.02. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidates' work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.

Minimum Education: Bachelor's degree
Minimum Experience: 4 years
Minimum Field of Expertise: Degree in directly related specialized scientific field. Previous specialized laboratory experience, knowledgeable in use of specialized laboratory equipment. Working knowledge of lab procedures, techniques and testing related to specialized scientific field. Computer literacy.

REQ20132300 Posted Date: 03/10/2025
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