Technical Writer/Document Control

Bureau Veritas•Plainfield, NJ

1d•$28 - $30

About The Position

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.

Requirements

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
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.

Responsibilities

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.
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