Quality Specialist

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 is 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.
• Experience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents.
• 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.
• Working knowledge of clinical study documents.
• Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
• Good verbal and written communication.
• Good interpersonal skills and ability to work in an international team environment.
• Willingness and ability to train others on study administration procedures.
• Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
• Integrity and high ethical standards.

Pulse Infoframe values diversity. We’re proud to be an equal opportunity employer and welcomes applicants from diverse backgrounds. If a job applicant requires an accommodation during the application or selection process, we will work with the applicant to meet the accommodation needs.

To apply, please send your resume to careers@pulseinfoframe.com.