POSITION SUMMARY

The QC Associate will support GMP manufacturing operations as part of the Cellectis Biologics quality control team. In a collaborative team environment, the QC Associate is responsible for completing daily QC testing and documentation including routine and non-routine microbiological and analytical testing of raw materials, in-process samples, finished products, and environmental monitoring in compliance with cGMP regulations.
This role supports the quality assurance of cell therapy products and ensures adherence to regulatory standards. This position reports to QC management.

EDUCATION AND EXPERIENCE

• Bachelor’s degree in a Life Science, with 1-3 years of hands-on related experience or education in a laboratory setting.
• Microbiology experience preferred.
• Basic understanding of GMP compliance required
• Experience following Standard Operating Procedures and Work Instructions to execute test methods
• Experience in the review and analysis of test data.

TECHNICAL SKILLS REQUIREMENTS / CORE COMPETENCIES

• Aseptic technique and cell culture expertise.
• Able to carry out daily tasks independently and with general instructions on new projects or assignments.
• Able to work on problems of limited scope and complexity byfollowing defined company procedures / practices, and GMP SOPs, to analyze situations or data from which answers can be readily obtained.
• Demonstrate good judgment in identifying resource needs and recommending solution.
• Ability to work in a collaborative team environment, open to seeking and receiving feedback and a self-starter.
• Flexible and capable of training team members cross training as needed by the QC department.
• Ability to prioritize and multi-task is essential.
• Strong attention to detail and ability to accurately document tasks in compliance with GMP requirements.
• Robust interpersonal skills and excellent oral and written communication skills.

PHYSICAL POSITION REQUIREMENTS

Safely works with hazardous and biohazardous materials using appropriate personal protective equipment (PPE). Requires the ability to follow proper gowning procedures and work in cleanrooms for uninterrupted periods of time of at least 4 hours. Requires the ability to sit or stand within a laboratory setting for long stretches of time. Frequently operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer. The person in this position needs to occasionally move about inside the office to access file cabinets and office equipment. Frequently walks around the laboratory, manufacturing, warehouse, and office areas to perform their job functions. May lift objects up to thirty pounds

• Performs routine QC tests for product release, stability, and in-process monitoring;
• microbiological assays including bioburden, endotoxin, sterility, total organic carbon (TOC), microbial identification, and growth promotion testing
• environmental monitoring of cleanrooms and controlled areas (air, surfaces, personnel).
• collection and testing water samples (WFI, purified water) and gas systems as applicable
• Review and analyze test results, identify deviations, and assist in investigations.
• Maintain and calibrate laboratory equipment and ensure proper documentation.
• Data review to ensure adherence to standard operating procedures and compliance with GMP regulations.
• Support method development, validation, and continuous improvement initiatives through participation in analytical method transfer feasibility studies, qualifications, and validations under appropriate supervision
• Participate in internal and external audits and implement corrective actions.
• Assist in facility and laboratory qualification and validation activities
• Author, revise, and train on SOPs, LTM’s and protocols
• May onboard and train new colleagues
• Laboratory sample receipt and tracking
• Other duties may be assigned