Active Vacancy

Position Summary:

As a QC Data Reviewer Associate I at CCRM you will be part of a diverse analytical team focused on designing and implementing a quality management program within the regenerative medicine field, including cell and gene therapy. You will work within the team to execute project tasks, as well as day-to-day operational duties. You will be a quality control (QC) team member in bringing new and innovative products to market to enable lifesaving advances in cell and gene therapies.

Responsibilities:

• Be responsible to CCRM and all its contracted facilities.
• Review all QC documentation according to Good Manufacture Practices (GMP), Good Documentation Practices (GDP) and CCRM’s Standard Operating Procedures (SOPs).
• Ensure accuracy and completeness of all raw data, data transcriptions, generated results and reports according to test methods, study protocols and applicable CCRM SOPs.
• Ensure all calculations related to data have been verified.
• Verify expiry date for all reagents and calibration date for all equipment used for testing, ensure they are within the due date.
• Ensure all tests are performed as per test method and/or study protocols. Identify any nonconformance during document review. Prevent release of non-compliant record(s) to client.
• Communicate the deficiency identified during document review to QC for corrections. Ensure that all deficiencies are corrected.
• With the support of the QC manager, ensure incident review, issue review and Out of Specification (OOS) investigation(s) are in compliance with CCRM’s SOPs and regulations.
• Perform data review in a timely manner. Release the data prior to due date.
• Other process related tasks that may arise.
• Demonstrate the CCRM values of purpose, integrity, excellence, accountability and collaboration, and motivate others to do the same.
• Continuously grow and adapt in a fast-moving field to keep yourself and the organization at the forefront of the regenerative medicine field, including cell and gene therapy.

Requirements:

• Bachelor’s degree in science (Cell Biology preferred) with 3+ years’ experience working in a GMP pharmaceutical company.
• Previous quality assurance (QA) or QC data review experience is a plus.
• Previous experience in a GMP lab with environmental monitoring, cell culture, ELISA, qPCR, endotoxin, enzyme assay, flow cytometry and SDS-PAGE is a plus.
• Demonstrate good understanding of GMP and GDP, and familiarity with quality control process.
• Well organized and able to deliver good quality work efficiently.
• Ability to work well with others and independently.
• Strong English written and oral communication.

Desired Characteristics:

• Understanding of Health Canada/U.S. Food and Drug Administration GMP regulations.
• Proven experience writing GMP documents (i.e. SOPs, validation procedures).
• Ability to deliver high quality work with attention to details.
• 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 (eQMS) and Laboratory Information Management System (LIMS)