Quality Specialist

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 Director of Quality and Product Delivery, the Quality Specialist (eTMF Specialist) is responsible for the day-to-day management of eTMF and QMS, including oversight of the review and approval of 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 ICH-GCP guidelines, other regulatory requirements, and standard operating procedures (SOPs). The role will also ensure the eTMFs for clinical studies and Quality documents are inspection ready at all times.

Key Responsibilities
• Main administrator for the company eTMF and QMS system.
• Understand and be willing to learn the eTMF and QMS system and its functionality.
• Maintain all company Quality documents to current revisions. This includes but is not limited to eTMF, SOPs and Policies.
• Ensure all Quality documents are current and trained by all respective employees, contractors and or consultants.
• Ensure all documents meet all regulation standards including but not limited to ICH-GCP and FDA.
• Assist with project management to oversee projects from scoping to delivery.
• Work cross departmental to ensure compliance with regulatory bodies.
• Assist with Quality audits where required.
• Reviewing and oversight on company deviations and CAPAs
• Recommend process improvements.

Qualifications
• Bachelor’s degree is preferred.
• 3-5 years of experience in clinical trials and regulatory documents is required.
• MasterControl experience a plus.
• 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.
• Experience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents.

Apply