QA Specialist

3 days ago

PointeClaire, Canada Cielo Verde Quebec Inc. Full time

**Your main responsibilities**:

- Review internal procedures (e.g., SOPs, equipment procedures, etc.) for consistency and regulatory compliance.
- Review equipment and computerized system lifecycle deliverables.
- Assist management (act as backup) to archive documents/records according to internal procedures and regulatory requirements which includes management of archived material and physical archives.
- Track and maintain controlled documents throughout their lifecycle as per procedural requirements.
- Maintain a solid understanding of the Cannabis Regulations.
- Conduct audits of routine processes and procedures of the facility.
- Accurately report audit findings in a clear and concise manner according to procedural requirements.
- Interact constructively with co-workers and clients.
- Execute other duties as assigned by management with flexibility and critical thinking.
- Escalate any potential issues/risks associated to quality, compliance, and data integrity to management.
- Participate in root-cause analysis and other problem solving/investigation activities to ensure that effective corrective/preventive actions are implemented, and processes are improved.
- Assist management to train personnel.
- Review raw data testing, analytical reports, and Certificate of Analysis (CoA) of each Cannabis product batch prior to its release for sale.
- Working knowledge of Good Documentation Practices, Good Manufacturing Practices and Cannabis Regulations as asset.
- Initiating and completing non-conformity reports and corrective action plans when necessary.
- Collaborate with Quality Control, Regulatory Affairs, Manufacturing and Product Development departments to ensure compliance with Health Canada regulations and guidelines.

**What we are looking for**:

- Bachelor’s degree in a scientific or medical discipline, preferably in biology or biochemistry, or equivalent, combined with a minimum of 1-2 years of experience in a related field and/or experience in quality assurance role, preferably in a pharmaceutical/CRO setting.
- A good understanding of applicable regulations and guidance documents, such as GPP (Good Production Practices) and (Good Documentation Practices).
- Fluently bilingual in English and French (both oral and written).
- Excellent verbal and written communication and interpersonal skills.
- Excellent multi-tasking skills and ability to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment.
- A strong sense of integrity and ethics.
- Proficient with the Microsoft Office suite.
- Experience with an ERP system is an asset.

**Salary**: $60,000.00-$65,000.00 per year

**Benefits**:

- Dental care
- Extended health care
- Vision care

Schedule:

- 8 hour shift

Ability to commute/relocate:

- Pointe-Claire, QC: reliably commute or plan to relocate before starting work (required)

**Experience**:

- quality assurance: 1 year (required)

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