Quality Specialist

3 weeks ago

London, Canada Pulse Infoframe Full time

**Company Background**

Pulse Infoframe is a global health technology company focused on cancer and rare/orphan diseases. We believe that medical advances are made when data is shared across boundaries, and we are leaders in Real World Data / Evidence. Our customers include leading global pharmaceutical and biotechnology companies, academic medical centers, and patient advocacy organizations. The Pulse culture is fueled by a dedicated team of research scientists, data engineers, and product managers committed to making a difference.

**Position Summary**

Pulse is seeking a Quality Specialist to join our Quality and Scientific team that builds and maintains our cloud-based platform that powers our products. Reporting to the Chief Financial Officer and Chief Executive Officer, the Quality Specialist is responsible for the day-to-day management of the Quality Management System (QMS) and electronic trial master file system (eTMF), including oversight of the review and approval of QMS and eTMF documents and generation of reports to measure completeness, accuracy, and timeliness of the eTMF and QMS. This role has a strong focus on ensuring that document management operations are performed with adherence to Good Clinical Practice (ICH-GCP) guidelines, other regulatory requirements, and standard operating procedures (SOPs). The role will also ensure the eTMF for clinical studies and Quality documents are always inspection ready.

**Key Responsibilities**
- MasterControl - Main administrator and super-user for the company eTMF and QMS system
- Document Management _
- Maintain all company Quality documents to current revisions. This includes but is not limited to eTMF, Standard Operating Procedures (SOPs) and Policies.
- Ensure all Quality documents are current and have been trained by all respective employees and contractors/consultants.
- Ensure all documents meet all regulation standards including but not limited to ICH-GCP and FDA.
- Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines.
- Internal Control _
- Key member of the internal control team and key point of contact for SOC 2 and ISO audits.
- Assist with other Quality audits where required.
- Review and report on company deviations and Corrective and Preventive Action Plans (CAPAs)

**Qualifications**
- Bachelor's degree
- 3-5 years of experience in a quality control setting (healthcare and real-world evidence experience preferred)
- Experience with clinical trials and regulatory documents is preferred
- MasterControl or other similar QMS system experience is preferred.
- American Society of Quality (ASQ) preferred
- Accountable and inquisitive, thinks "outside the box ".
- Must be methodical, compliant to processes yet flexible when needed.
- High ability to manage priorities and Local Study Team expectations.
- Independent yet able to work cohesively with a team.
- Advanced computer skills to increase efficiency in day-to-day tasks
- Excellent verbal and written communication.
- Good interpersonal skills and ability to work in an international team environment.
- Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities.
- Integrity and high ethical standards.

**Location**

Pay: $60,000.00-$80,000.00 per year

Schedule:

- Monday to Friday

**Education**:

- Bachelor's Degree (required)

**Experience**:

- quality assurance: 3 years (required)

Work Location: Hybrid remote in London, ON N5X 4E7

Application deadline: 2024-11-08
Expected start date: 2024-12-01

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