Quality And Document Control Associate

Traferox creates, manufactures, and commercializes products that employ technologies invented by the surgeon team of the University Health Network (UHN) to improve surgical outcomes and save patients’ lives.

Location: Work will be performed in the company’s place of work at the Traferox facility located at 3505 Laird Rd Mississauga, ON L5L 5Y7, Ontario. No International travel required for this role.

Responsibilities

·Coordinate the numbering, submission, review, approval, release, and training of product and QMS documentation.

·Review and approve production-related purchase requests to ensure all quality requirements are fulfilled.

·Coordinate the incoming activities with production, reviewing and approving inspection records and issuing nonconformances as required.

·Monitor and enforce good manufacturing practices to ensure compliance within the manufacturing facility.

·Perform regular sampling, testing, and analysis of raw materials, in-process samples, and finished products to verify compliance with specifications and quality standards.

·Conduct thorough inspections and audits of production processes, equipment, and documentation to identify any deviations from GMP standards and company procedures.

·Review and approve batch records, production documentation, and quality control records to ensure accuracy and adherence to GMP requirements.

·Conduct, monitor and trend cleanroom sampling for environmental control monitoring.

·Initiate, investigate, and follow up on nonconformances and CAPA’s as assigned.

·Initiate and assist in the qualification of equipment.

·Initiate and assist in the qualification of suppliers.

·File quality records in physical and digital records and retrieve files as requested.

·Follow up on open tasks and issues and ensure update of quality system lists and logs.

·Prepare monthly and ad hoc QMS and project reports.

·Assist in data entry tasks for document and product change requests.

·Assist in computer system validation activities.

·Provide training and guidance to employees on GMP principles, quality control procedures, and best practices to promote a culture of quality and continuous improvement. Other duties as assigned.

Qualifications

Education:

·Graduate from college or university in sciences or related field. B. Sc degree preferred.

Experience:

·1-2 years experience in regulated environment for medical devices or pharmaceutical manufacturing

·Knowledge of GMP regulations, quality control principles, and pharmaceutical manufacturing processes

·Experience working in a cleanroom/controlled environment is an asset

·Preferred experience in start-ups requiring the ability to work on multiple tasks and take initiative in continuous improvement of the QMS.

·Familiarity with regulatory requirements from agencies such as the FDA, EMA, and ICH

·Experience working with computerized quality management / PLM systems is an asset.

Skills:

·Ability to read and interpret instructions, communicate effectively and display excellent attention to detail.

·Hands-on experience with Excel office 365 application and SharePoint

·Ability to become proficient in Electronic Document Management Systems (EDMS)

·Strong work ethic and passion to learn and contribute as a member of a high performing team

·Strong writing skills including ability to develop technical writing skills

·Excellent communication and organization skills

·Proficient typing and editing skills

·Ability to handle and prioritize multiple projects simultaneously.

·Strong interpersonal skills