Quality Control Associate I (Microbiology)

Job Responsibility: Position Summary: As a Quality Control Associate I (Microbiology) at CCRM, you will be part of a diverse bioengineering team focused on designing and implementing a quality management program within the cell and gene therapy and regenerative medicine fields. You will provide technical expertise and will work within the team to define and execute project tasks, as well as day-to-day operational duties. You will be a Quality Control (QC) team member who helps to bring new and innovative products to market to enable life-saving advances in cell and gene therapy and regenerative medicine. As a QC Microbiology team member, you will be responsible for an environmental monitoring (EM) program in the facility, as well as QC testing for batch release. Responsibilities:

• Maintains a level of expertise in the QC Microbiology team regarding equipment and operations to support manufacturing for CCRM and its clients.
• Provides technical support to help create and revise an aseptic strategy policy for manufacturing to implement in the Centre for Cell and Vector Production (CCVP) and all CCRM-managed sites.
• Designs, organizes and maintains the standard operating procedures (SOPs) that describe equipment's key functions including, but not limited to, the operations and maintenance procedures.
• Provides recommendations in the areas of microbiology, aseptic processing and contamination control program and mitigation planning.
• Analyzes existing EM and other QC-related SOPs for content.
• Conducts EM to support current and future operations.
• Maintains documentation for the EM program and studies data trending for the facility, at regular intervals. Plans corrective action if any deviation is observed.
• Facilitates the training of end-users on EM sampling requirements, sample handling and other quality procedures, if applicable.
• Creates equipment log books/records and a preventative maintenance schedule for applicable equipment.
• Maintains equipment, monitors process areas and ensures they are prepared for use.
• Supports the monitoring of deviations for the manufacturing facilities and, if they are above alert/action limit, liaises with other departments for timely resolution.
• Supports third-party testing by our approved partners.
• Performs aseptic gowning qualification and maintains personnel qualifications.

• Performs QC microbiology testing and supports any outsourced testing for lot release/stability studies.

• Conducts troubleshooting when testing failures occur.
• Writes protocols, tests, methods and technical reports, as required.
• Responsible for other process-related tasks that may arise.
• Enforces Good Manufacturing Practices (GMP) in everyday tasks.
• Demonstrates CCRM's values of purpose, integrity, excellence, accountability and collaboration, and motivates others to do the same.
• Continuously grows and adapts in a fast-moving industry to keep yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.

Requirements:

• Bachelor of Science degree in microbiology or biology preferred.
• 1-3 years previous related experience in a GMP environment.
• Strong presentation skills and English written and oral communication skills.

Desired Characteristics:

• Understands Health Canada/U.S. Food and Drug Administration GMP regulations and quality assurance principles.
• Proven experience writing GMP documents (i.e. SOPs, validation procedures).
• Able to deliver high-quality work with attention to detail.
• Able to quickly grasp complex technical concepts and make them easily understandable in text and pictures.
• Excellent communication and interpersonal skills with assertive, responsible and accountable attitude.
• Strong working knowledge of Microsoft Office.
• Basic familiarity with an electronic quality management system, laboratory information management system and manufacturing execution systems.

Revision Number : CCRMQCAIMB-20240613