Quality Control Associate Ii

5 months ago

Toronto, Canada Centre for Commercialization of Regenerative Medicine Full time

**About CCRM**:
Deliver - GMP Contract Manufacturing - Quality Control Associate II

**Position Summary**:
As a Quality Control Associate II 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 part of a quality control (QC) team bringing new and innovative products to market to enable life-saving advances in cell and gene therapy, and regenerative medicine. This position has responsibilities to CCRM and all its contracted facilities.

**Responsibilities**:

- Design and implement a QC service program to support current and future operations.
- Conduct other process-related tasks that may arise.
- Help set up a standard QC regiment for the applicable facilities.
- Execute QC testing, following the company’s Standard Operating Procedures (SOPs) and current good manufacturing practices (cGMP) guidelines.
- Conduct trouble shooting where testing failures occur.
- Write protocols, drafts methods and technical reports as required.
- Keep all records and lab notebooks in good order. Analyze testing data and provide data for quality assurance (QA) review in a timely manner.
- Ensure equipment is maintained in good order; perform calibrations and qualifications as required.
- Provide guidance and training to junior QC associates to the proficiency level required to perform tasks independently.
- Coordinate method transfers between clients and the Research and Development group.
- Perform method development, qualification and validation as required.
- Demonstrate CCRM’s values of purpose, integrity, excellence, accountability and collaboration, and motivate others to do the same with assertive and responsible attitude.
- Strive to continuously grow and adapt in a fast-moving field to keep yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.

**Requirements**:

- Bachelor's degree in science (Cell Biology preferred) with at least 4 years GMP experience.
- Experience with cell culture, ELISA, qPCR, endotoxin, enzyme activity.
- Strong English written and oral communication.
- Ability to work well with others and independently.
- Ability to manage and coordinate multiple projects in a fast-paced environment.

**Desired Characteristics**:

- Understanding of Health Canada/U.S. Food and Drug Administration GMP regulations and QC principles.
- Proven experience writing GMP documents (i.e. SOPs, validation procedures).
- Ability to deliver high quality work with careful attention to details.
- Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures.
- Excellent communication and interpersonal skills
- Strong working knowledge of Microsoft Office.
- Basic familiarity with an electronic Quality Management System and Laboratory Information Management System.
- Training in GMP.

CCRM is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada.

CCRM is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.

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