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

Job Description

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.

 

Key Responsibilities:

 

 

Training operations

• 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.

 

document control operations

• 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

 

 

AUDIT & INSPECTION SUPPORT

• 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.

 

business ownership and system ADMINisTRATION

• 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

 

 

sTRATEGIC pARTNERSHIP and team dynamics

• 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.

 

 

Minimum qualifications:

• 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.

 

PREFERRED QUALIFICATIONS:

• Experience with Cornerstone OnDemand LMS and/or Veeva DMS
• Essential skills and knowledge
  • 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
  • High