Active Vacancy

Position Summary:

As a Quality Control Associate I 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.

Responsibilities

• This position has responsibilities to CCRM and all its contracted facilities.

• Implement a QC service program to support future and current operations.

• Execute QC testing, following the company’s Standard Operating Procedures (SOPs) and cGMP guidelines.
• Report test failures to QC manager. Conduct troubleshooting with support of senior QC Associates.
• Write protocols, test methods and technical reports as required.
• Keep all records and lab notebooks in good order. Analyze testing data and provide data for QA review in a timely manner.

• Ensure equipment is maintained in good order, perform calibrations and qualifications as required.

• Coordinate method transfers between clients and the Research and Development (R&D) group.
• Perform method development, qualification and validation as required under supervision of senior QC associates.

• Perform additional tasks as required.

• Demonstrate CCRM’s values: Purpose, Integrity, Excellence, Accountability and Collaboration, and motivate others to do the same.
• Continuously grow and adapt in a fast-paced environment to keep yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.

Requirements

• Bachelor’s Degree in a scientific field, Cell Biology preferred.
• Experience with cell culture, ELISA, qPCR, SDS-PAGE, DNA/RNA analysis, and enzyme activity.
• Strong English written and oral communication.
• Ability to work well with others as well as independently.
• Ability to manage and coordinate multiple projects in a fast-paced environment.

Desired Characteristics

• Understanding of Health Canada/US Food and Drug Administration (FDA) GMP regulations and Quality Control principles.
• Proven experience writing GMP documents (i.e. SOPs, validation procedures).
• Ability to deliver high quality work with strong attention to detail.
• Excellent communication and interpersonal skills with assertive, responsible, and accountable attitude.
• Strong working knowledge of Microsoft Office Suite.
• Basic familiarity with electronic Quality Management Systems (eQMS) and Laboratory Information Management Systems (LIMS).
• GMP training/experience.