Quality Associate

Number of vacancies: 1

Site: 3505 Laird Rd Mississauga Ontario

Department: Quality and Regulatory

Reports to: Manager Quality

Status: Permanent Full-time

Position Summary:

The position of Quality Associate will be an integral member of the Quality and Regulatory department. The Quality Associate will contribute to the development and maintenance of manufacturing and quality system procedures and work instructions to ensure compliance with global regulations and standards in a regulated medical device environment.

Key responsibilities include:

• 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.
• Manage label printing process for the finished goods which includes managing label inventory inspection and zebra printer maintenance..
• Review and approve batch records production documentation and quality control records to ensure accuracy and adherence to GMP requirements.
• Manage nonconforming products including identification and segregation creation and follow up of nonconforming material reports and hold Material Review Board meetings as needed.
• Initiate investigate and follow up on CAPAs as assigned.
• Ensure completion of equipment qualification and management of the equipment master list. Manage the equipment calibration program.
• Monitor the supplier management program. Ensure suppliers are qualified and assist in this process as needed. Complete monthly supplier reviews and hold Supplier Review Board meetings as needed.
• 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. BSc 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

Remote Work :

No

Employment Type :

Full-time