Sterility Assurance Associate I - Toronto, Canada - Centre for Commercialization of Regenerative Medicine

Centre for Commercialization of Regenerative Medicine

Verified Company

Toronto, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

About CCRM:

Position Summary:

As a Sterility Assurance 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 assurance team member in bringing new and innovative products to market to enable life-saving advances in cell and gene therapy and regenerative medicine.

As a SA team member will be responsible for Sterlity assurance and contamination control program in the facility.

Responsibilities:

Maintain a level of expertise in the SA team regarding equipment and operations to support manufacturing for CCRM and its clients.
Create and revise an Aseptic Strategy Policy for CCRM manufacturing to implement in the Centre for Cell and Vector Production (CCVP) and all CCRM managed sites.
Design, organize and maintain the Standard Operating Procedures (SOPs) that describe our equipment's' key functions including, but not limited to, the operations and maintenance procedures.
Analyze existing sterility assurance SOPs for content, focusing on regulatory requirements.
Oversee an Environmental Monitoring program to support current and future operations.
Maintain documentation for the Environmental Monitoring program and study data trending for the facility, at regular intervals. Plan corrective action if any deviation is observed.
Help set up an aseptic strategy for the applicable facilities.
Facilitate the training of endusers on sampling requirements, sample handling and other quality procedures (if applicable).
Create equipment log books/records and a Preventative Maintenance (PM) schedule for applicable equipment.
Maintain equipment, monitor process areas and ensure they are prepared for use.
Lead the monitoring of deviations and above alert/action limit, for the manufacturing facilities and liaise with the other departments for timely resolution of these events.
Manage the thirdparty testing by our approved partners and take part in the qualification processes (as needed) of thirdparty laboratories.
Perform aseptic gowning qualification and maintaining personnel qualifications
Be responsible for other processrelated tasks that may arise.
Demonstrate CCRM's values of purpose, integrity, excellence, accountability and collaboration, and motivate others to do the same.
Continuously grow and adapt in a fastmoving industry to keep yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.

Requirements:

Bachelor of Science degree in microbiology or biology, preferred.
Has 02 years or previous, related experience
Strong presentation skills and English written and oral communication skills.

Desired Characteristics:

Understanding of Health Canada/US Food and Drug Administration Good Manufacturing Practices (GMP) regulations and QA principles.
Proven experience writing GMP documents (i.e. SOPs, validation procedures).
Ability to deliver high quality work with specific attention to details.
Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures.
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, Laboratory Information Management System and Manufacturing Execution Systems.

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.