Quality Co-op Student

3 months ago

Toronto, Canada Centre for Commercialization of Regenerative Medicine Full time

**About CCRM**:
**Department**: Deliver

**Co-Op Terms**: 12-16 months, On-Site Working Arrangements

**Role Summary**:
As a Quality Co-Op Student at CCRM, you will support the Good Manufacturing Practices (GMP) of regulated manufactured products while motivated by the opportunity to enable the clinical translation of cell and gene therapies. You will work with the team to define and execute project tasks and day-to-day duties, with a focus on issuing and maintaining documents, providing material release support, and creating reports when required. You will assist with bringing new and innovative products to market to enable life-saving advances in cell and gene therapy, and regenerative medicine.

**Responsibilities**:

- Assist with maintaining the quality management system (QMS), ensuring documents are current and in good order.
- Issue and execute material specifications sheets in a timely manner.
- Issue various quality documents, such as logbooks, forms, batch records, or specifications.
- Assist with maintaining and continuously improving the quality systems.
- Work with team members to draft various documents in accordance with GMP regulations.
- Assist with deviations and corrective and preventative action (CAPA) tasks, as needed.
- Initiate change controls, as required.
- Develop key performance indicator (KPI) reports.
- 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.

**Requirements**:

- Currently enrolled in a College or University program in Regulatory Affairs, Quality and/or Compliance.
- Strong English written and oral communication skills.
- Able to follow standard operating procedures.
- Able to prioritize and manage conflicting demands.
- Basic computer skills.
- Some physical lifting and carrying required.
- Able to work with minimum supervision, self-driven, and able to perform well independently or in a team-oriented environment.

**Desired Characteristics**:

- Understanding of Health Canada and U.S. Food and Drug Administration’s GMP regulations.
- Experience with an electronic QMS.
- Independent and detail-oriented self-starter with excellent analytical skills and able to multitask and succeed in a team environment.
- Demonstrated initiative and the ability to deliver high-quality outcomes.

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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