Sterility Assurance Associate I

Position Title: Sterility Assurance Associate I

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 Sterility assurance and contamination control program in the facility.

 Responsibilities:

• This position would have responsibilities to CCRM and all its contracted facilities;
• Maintain level of expertise in the SA team regarding equipment and operations to support the manufacturing of CCRM and its clients.
• Create an Aseptic Strategy Policy for the CCRM manufacturing and implement at CCVP and all CCRM managed sites.
• Design, organize and maintain the Standard Operating Procedures (SOPs) that describes the equipment key operations including, but not limited to the operations and maintenance procedures;
• Serves as an SME in Microbiology, aseptic processing and Contamination Control program and mitigation planning.
• Analyze existing SA SOPs for content, focusing on regulatory requirements;
• Design,implementand oversee EM program to support the future and current operations;
• Maintain documentation for Environmental Monitoring program and study data trending for the facility in regular interval. Plan corrective action if any deviation observed.
• Help set up a aseptic strategy for the applicable facilities;
• Facilitate the training of end-users on sampling requirements, sample handing and other quality procedures;
• Create Equipment log books/records and Preventative Maintenance (PM) schedule for applicable equipment;
• Maintain equipment, monitor process areas and ensure they are prepared for use; • Lead the deviations, above alert/action limit, for the manufacturing facilities and liase with the other departments for timely resolution of these events.
• Manage the 3rd party testing by our approved partners, take part in the qualification processes (as needed) of third party laboratories.
• Manages and approves operation with third party laboratory for microbial testing. • Responsible for Aseptic Gowning qualification and maintaining personnels qualification.
• 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 cell and gene therapy and regenerative medicine fields.

Requirements:

• Bachelor’s degree in Science (Microbiology or biology preferred)
• Strong presentation skills, strong leadership skills
• Strong English written and oral communication.

Desired Characteristics:

• Understanding of Health Canada/US Food and Drug Administration GMP regulations and Quality Assurance 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(eQMS), Laboratory Information
• Management System (LIMS), MES systems
• 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.