Job Description

Quality Improvement Specialist

Looking for a career that makes a difference? CellCarta, a clinical research company, is seeking a Quality Improvement Specialist to join our dynamic team. As a Quality Improvement Specialist at CellCarta, you\'ll have the opportunity to use your expertise and passion for quality to ensure that our services meet the highest industry standards. Come work with a team of talented individuals who are committed to making a positive impact on human health and well-being. Apply today and take the first step towards an exciting new career with CellCarta!

Summary

The Quality Improvement Specialist will (i) manage exception documentation (e.g., investigations, deviations, CAPAs) (ii) compile data and perform trend analyses and other analytics, (iii) build dashboards to track performance, (iv) propose improvements to enhance robustness of processes and systems, minimizing repeat errors and drive continuous improvement in the operation.

Responsibilities

• Perform investigations;
• Manage exception documentation;
• Complete trend analysis;
• Drive continuous improvement in processes and systems;
• Communication with senior operations and quality management on metrics, trends and the timeliness of committed actions;
• Drive completion of KPIs within committed timelines;
• Ensure all information and data is adequately compiled in the deviation, investigation or CAPA reports;
• Participate in interviewing personnel, as applicable, to facilitate the investigation process
• Apply effective troubleshooting of laboratory, equipment, and process failures and non-conformances;
• Apply effective root cause analysis principles to identify root cause and suggests immediate actions to mitigate any risks;
• Coordinate and leads cross-functional meetings to communicate critical findings and proposes recommendations to management;
• Drive appropriate change control and leads improvement initiatives;
• Responsible to train employees on investigation processes and techniques;
• Assist in sponsor/regulatory audits.

Education

• Bachelor of Sciences (B.Sc) in Engineering.

Main Requirements

• 2-3 years of quality engineering experience in a pharmaceutical, medical device or diagnostic laboratory environment (or equivalent). Experience with clinical trials a plus;
• Well versed in GCP/GCLP requirements as applicable to the activities supporting clinical trial sample analysis;
• Strong understanding of root cause analysis, investigation techniques and risk analysis;
• Leadership qualities;
• Self-motivated, adaptable, and positive attitude;
• Excellent communication in English and French (oral and written);
• Organized and detail oriented;
• Can prioritize multiple assignments and shifts in priorities;
• Capable of working in a matrix organizational structure;
• Knowledge of Master Control an asset.

Benefits

CellCarta is made up of dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world!

We offer a wide range of benefits including:

• Competitive wages
• Medical, dental, and vision benefits
• Retirement savings plan
• Vacation and sick time
• Career development opportunities
• Continuing education

Join us as we make an impact on patient therapy!

About CellCarta

CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The company operates globally with over 1,000 employees in its 11 facilities located in Canada, USA, Belgium, Australia, and China.

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CellCarta