Document Number: NEO-FRM-625 / Revision: A / Effective Date: 2014 Jun 02
Company Confidential, Neovasc Inc. / Page Number: 2 of 2
Job Title: / Tissue Sterilization Technician
Reports To: / Production Manager / Production Supervisor
Location: / 13562 Maycrest Way, Richmond, BC V6V 2J7
Date: / 2017 January 26
Purpose/Role
A brief description of the primary responsibilities for which the employee is accountable
To work with biological tissue and ensure it is assembled, processed, and sterilized in accordance with established procedures within the Quality Management System.Position Description
A listing of the deliverables to be accomplished, including specific duties/activities that make up the job
· Performing Chemical Sterilization (Bioburden Reduction Process, Packaging and Terminal sterilization)· Applying and maintaining product traceability; Keeping accurate records during processing on the Device History Records (DHR), Sterilization forms, Rework Sheets, reprocessing reports and other relevant product records
· Performing torque and integrity testing of final packaging.
· Preparing and ensuring materials, equipment, instruments, and process relevant supplies. Coordinating inventory with other departments
· Performing Daily Monitoring and Environmental Monitoring during sterilization process, including incubation, monitoring and proper storage for Microbial Identification purposes.
· Wearing cleanroom apparel – respirator, cleanroom gowning for extended periods
· Adhering to the necessary controls and established procedures
· Supporting manufacturing in current products
· Working with other team members to support the development of biologic R&D tissue projects Working with customer project relevant processes
· Handling of pericardial tissue
· Ensuring adequate prioritization of production activities
· Assisting with cleanroom operations and maintenance
· Other related duties as required
Qualifications
Represents the desired qualifications but may not reflect the employee’s existing qualifications
Education:· Post secondary education or relevant experience
Experience:
· Previous production and/or manufacturing experience in a cleanroom setting an asset· Sewing/needlework experience is a strong asset
· Familiar with sterilization processes and aseptic techniques is an asset
· Working experience in cleanroom and chemical laboratory is an asset
Skills:
Very detail oriented
Logical and methodical approach to tasks
Ability to work on own or as part of a team
Ability to follow written and verbal instructions
Good communication skills
The purpose of this description is to provide a concise statement of the major responsibilities of this position in a standardized format. It is not intended to describe all the elements of the work that may be performed and should not serve as the sole criteria for personnel decisions and action.
Approvals:
______
Employee (signature) Date
______
Manager (signature) Date
NEO-TMP-004 Rev B, Effective Date: 2014 Mar 07 / Document is UNCONTROLLED COPY unless it is stamped CONTROLLED COPY.