International Point of Care Hiring for Quality Assurance Associate -Junior at Toronto, ON Full Time

This position will be responsible for developing, coordinating, implementing, and maintaining quality system processes required throughout the product life cycles including the development, manufacture, and distribution of products in a manner that is compliant with International Point of Care, Inc. policies and procedures and applicable Regulations.

Education and Experience:
Post-secondary education in a scientific discipline (biology, molecular biology, microbiology, biochemistry or related field) or equivalent industry experience in a regulated company i.e. experience of working in a GMP environment Personal Characteristics and Professional Skills (Preferred)

Working knowledge of applicable Regulatory requirements and Quality Standards and guidelines (ISO 13485, 21CFR Part820, EU IVDD/IVDR), and accepted quality practices and guidelines.

Strong computer skills.

Strong communication skills (written and verbal).

Organized and detail-oriented with the ability to multi-task in a fast-paced work environment.

Team player that can interact effectively with personnel at all levels.

Essential Functions/Major Responsibilities:
Ability to focus on quality details, and work effectively under pressure to meet deadlines.

Perform tasks that will support the Quality Assurance department with reviewing technical documents and batch records for the purposes of releasing product.

Performs QA document control functions, including document processing, approving, distributing, and archiving in accordance with document control processes.

Assist in drafting quality assurance policies and procedures and maintain quality records.

Assist in product release including issuing lot numbers, reviews records in the DHR for adequacy, ensure activities were completed in accordance with the approved DMR.

Assist in the investigation of customer complaints and non-conformances.

Assist in the evaluation of audit findings and implement appropriate corrective actions.

Participates in management review activities and provides input.

Ensures all tasks are completed in a timely manner and in accordance with accepted quality practices.

Assist the QA Department in ensuring ongoing compliance with quality and applicable Regulatory requirements as required.

Work with the Product Development department to ensure that quality deliverables are obtained, reviewed, and approved as appropriate.

Performs other duties & projects as assigned.