Document Controller/Tech Writer III

Description

• Resolve escalated and high-profile client requests and issues.
• Provide enhanced guidance and technical training to internal staff.
• Maintain up to date knowledge of current procedures.
• Follow the guidelines set forth with clients and in the Bureau Veritas Consumer Products Services, Inc Quality, Health, Safety, Security and Environmental policies and procedures.
• Develop and implement administrative policies and procedures to enhance efficiency
• Serves as secondary support in multiple additional areas.
• Schedule appointments and maintain calendars
• Report equipment and system technical issues to the appropriate contacts.
• Follows the guidelines set forth in by clients and the Bureau Veritas Consumer Products Services, Inc Quality Manual and Safety / Chemical Hygiene Plan.
• Provide support for meeting preparation
• Collect, create, maintain and track progress of projects through visualization tools (example PowerBi, Excel, PowerPoint or Dashboards) to manage status and progression of defined project improvements/key initiatives.
• Perform basic research and information gathering as needed
• Be the subject matter expert for deviations, procedure and technical documentation progress and tracking
• Interprets information from multiple sources and provides analysis.
• Lead team meetings to present projects progress, data and up action items (PowerPoint)
• Manage and prioritize multiple projects simultaneously
• Monitor, update and look for trends in documentation and reports related to clinical supply chain, clinical trial kit distribution, pharma labeling and device manufacturing (Regulatory, FDA, TSA or GMP environment)
• Identify, troubleshoot and solve escalated technical issues.
• Maintain supplies, workstation cleanliness, and equipment, as required.
• Write or edit procedure as requested including developing training materials
• Perform data entry and report project updates
• Performs work in coordination with clients, coworkers, and supervision from management
• Answer and direct incoming internal and external communications
• As Document Controller/Editor ensure technical procedural revision review and approval workflows are achieved.
• Assist with basic data entry and record-keeping tasks
• Act in partnership with clients and management to support process improvement development
• Provide general administrative and clerical support, such as filing, photocopying, and organizing documents
• Author technical documents related to change management, intra-company issues with the use of systems such as Trackwise/Veeva Vault.
• Gather, track and complete governance documents related to project improvements, department agendas and key initiatives across several department functions (progression of current and/or new additions).
• Adhere to the requirements of the BV-CPS Quality System.
• Comply with clients and Bureau Veritas Consumer Products Services, Inc management systems in accordance with appropriate regulatory agencies.
• Is a subject matter expert (SME) in assigned area and maintains up to date knowledge of current regulations / industry standards, and protocols.

Requirements

• Able to troubleshoot with N+1 for any client issues or questions with the aim of enhancing client satisfaction and improving client relations.
• High level of attention to detail
• Strong organizing/multi-tasking skills, document tracking and naming conventions
• Ability to get along with others with excellent interpersonal communication and networking skills
• Minimum of 3 year(s) of experience in a cGMP quality warehouse environment or closely related field
• Ability to lead meetings (PowerPoint), present and collect data as well as follow up action items
• Bachelor’s Degree and 3-5 years’ experience in a project management or quality related field
• Proficiency with computer systems for example PowerBi, PowerPoint, Tableau, Trackwise, Excel, Veeva Vault etc.
• Demonstrated strong written and verbal communication skills
• Knowledge of documentation control and practice
• Strong clear communicator speaking in large groups
• Ability to work well in a team environment and resolve issues quickly
• Project management and project coordination experience

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance