Technical Writer/Document Control

Overview:

Business Title: Business Support III

Position Title: Technical Writer Document Control

Division: Consumer Products Services

Entity: ATL

Location: Plainfield, IN

Reports to: ATL Manager

FLSA: Non-exempt

Hours Worked: Typically, Monday through Thursday 7:30 AM – 4:00 PM. However, must be flexible to meet business needs or cover shifts a requested

Position Summary:

The Technical Writer/Document Control serves in a key role providing project support to the distribution operations across different functional areas (Operations, Quality, & Compliance) by facilitating, authoring documents, writing and following up on deviations for intracompany issues. This position will review, track and follow up on deviation responses and timelines. The role is highly independent and will report to the manager providing input to enable progression on key initiatives.

Duties and Responsibilities:

It is everyone’s responsibility to live out our Values and Absolutes by Shaping a World of Trust while ensuring responsible progress.

• Provide general administrative and clerical support, such as filing, photocopying, and organizing documents
• Answer and direct incoming internal and external communications
• Schedule appointments and maintain calendars
• Assist with basic data entry and record-keeping tasks
• Provide support for meeting preparation
• Perform basic research and information gathering as needed
• Performs work in coordination with clients, coworkers, and supervision from management
• Able to troubleshoot with N 1 for any client issues or questions with the aim of enhancing client satisfaction and improving client relations.
• Perform data entry and report project updates
• Report equipment and system technical issues to the appropriate contacts.
• Maintain supplies, workstation cleanliness, and equipment, as required.
• 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.
• Comply with clients and Bureau Veritas Consumer Products Services, Inc management systems in accordance with appropriate regulatory agencies.
  
  

Additional Responsbilities for Technical Writer/Document Control:

• Follows the guidelines set forth in by clients and the Bureau Veritas Consumer Products Services, Inc Quality Manual and Safety / Chemical Hygiene Plan.
• Adhere to the requirements of the BV-CPS Quality System.
• Other duties as defined by Manager, department needs and workload
• Serves as secondary support in multiple additional areas.
• Resolve escalated and high-profile client requests and issues.
• Is a subject matter expert (SME) in assigned area and maintains up to date knowledge of current regulations / industry standards, and protocols.
• Manage and prioritize multiple projects simultaneously
• Interprets information from multiple sources and provides analysis.
• Identify, troubleshoot and solve escalated technical issues.
• Provide enhanced guidance and technical training to internal staff.
• Write or edit procedures as requested including developing training materials
• Act in partnership with clients and management to support process improvement development
• Develop and implement administrative policies and procedures to enhance efficiency
• 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.
• 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).
• Author technical documents related to change management, intra-company issues with the use of systems such as Trackwise/Veeva Vault.
• As Document Controller/Editor ensure technical procedural revision review and approval workflows are achieved.
• 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)
• Lead team meetings to present projects progress, data and up action items (PowerPoint)
• Be the subject matter expert for deviations, procedure and technical documentation progress and tracking
• 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.
• Comply with clients and Bureau Veritas Consumer Products Services, Inc management systems in accordance with appropriate regulatory agencies.
• Other duties as defined by manager, department needs and workload.
  
  

Long Description

Skills & Proficiencies:

• Strong organizing/multi-tasking skills, document tracking and naming conventions
• Strong clear communicator speaking in large groups
• Project management and project coordination experience
• High level of attention to detail
• Knowledge of documentation control and practice
• Ability to lead meetings (PowerPoint), present and collect data as well as follow up action items
• Ability to get along with others with excellent interpersonal communication and networking skills
• Demonstrated strong written and verbal communication skills
• Ability to work well in a team environment and resolve issues quickly
• Proficiency with computer systems for example PowerBi, PowerPoint, Tableau, Trackwise, Excel, Veeva Vault etc.
• Positive attitude
• Adheres to Company Values
  
  

Education and Experience:

• Bachelor’s Degree in Business, Technical Writing or closely related field
• Minimum of 3 year(s) of experience in regulatory GMP environment
  
  

An equivalent combination of education and experience may be accepted in lieu of above.

Compensation Range: $27.50 - $30.00 per hour (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as locations, education, experience, and skillset).