Senior Quality Specialist, Document Control and Training Operations - Pharmaceutical (Contract) 28159

Vertex Pharmaceuticals•Boston, MA

1d•$55 - $60

About The Position

The Senior Quality Specialist works cross-functionally to support multiple departments’ day-to-day documentation and training lifecycle activities within the Document Management System (DMS) and Learning Management System (LMS). The Sr. Quality Specialist uses their regulatory and industry knowledge to work with a high degree of independence and is adept at troubleshooting problems, with an emphasis on critical thinking skills. They are experts on internal procedures and system functionality and ensure that documentation and training materials meet procedural and content requirements of these procedures, and applicable regulatory requirements. This is a multifaceted, fast paced position that requires excellent time management, organization, prioritization and communication skills.

Requirements

Bachelor’s degree and 3 – 5 years of relevant work experience, or relevant comparable background
Experience with DMS and/or LMS
Proficient in Zoom, Teams and the Microsoft Office suite of products, particularly MS Word.
Strong attention to detail and work ethic.
Highly organized and self-motivated.

Nice To Haves

Experience with Cornerstone OnDemand LMS and/or Veeva DMS
Strong problem-solving skills
Learning analytics and data analysis techniques
Excellent verbal and written communication skills
Experience and ability to work effectively with a wide range of people, demonstrating high emotional intelligence
Highly developed interpersonal skills
Manage multiple projects concurrently with aggressive deadlines
Adapt and thrive in a fast-paced, changing environment
Willing to work flexible hours and days, when needed

Responsibilities

Complete Training Impact Assessments (TIAs)
Provides customer support (troubleshooting, answering questions, addressing incident tickets)
Creates and maintains learning objects, user groups, curricula, and learning assignments within LMS.
Manages training materials within DMS.
Collaborates with business partners in developing on-the-job (OJT) training curricula, task assessments.
Triage incoming daily communications to QA Training team email
Assists in development of training process changes or continuous improvements.
Provides guidance on general training issues of varying complexity.
Assist Document Owners throughout the lifecycle of their documentation, for all document types
Review documentation and complete a Document Control Checklist
Complete applicable tasks within DMS in a timely manner with a high degree of accuracy
Triage incoming daily communications to GPOC Document team email
Triage daily tasks assigned to the team within the DMS
Send monthly communications regarding periodic review per escalation path process
Maintain internal DMS dashboards and metrics for team
Daily Documentation team administrative activities
Maintain Document Management SharePoint Portal and VNet
Provide support to Document Owners during 3x/week Open Office Hours
Understanding of company policies, procedures, and standards
Provide support in the preparation for, conduct of, and follow-up activities associated with regulatory inspections and client audits
May provide requested documentation or reports from LMS or DMS to inspection team, as needed.
May serve as liaison for Operations Managers during inspections.
Executes ServiceNow GxP training assignments requests
Resolves ServiceNow incident tickets submitted by learning community.
Maintains ServiceNow role-based catalog.
May confirm training completion and appropriate role assignment for system access requests, and approve applicable tickets via ServiceNow, as needed, for DMS, LMS and Quality Management System (QMS)
Provides support to business administrators for LMS and DMS
May assist with execution of validation test scripts for system changes
Closely partners with Strategic Documentation Partner (SDP) and Strategic Training Partner (STP) to effectively manage projects and initiatives across Document Control and Training
Assists fellow team members in a busy, dynamic environment via several mediums (Teams, Outlook, Zoom, etc.) as needed.
Assists with the onboarding of new Operations team members, as needed.