Quality Document Control Specialist

Essential / Key Job Responsibilities

• Participates in regulatory compliance audits and inspections.
• Participates in investigations.
• Completes applicable job-specific training.
• Effectively manage the end-to-end change lifecycle and identify process improvements where possible.
• Day to day management of change requests
• Reporting of change to both internal and customer management teams
• The position will identify and drive continuous improvements to the quality and efficiency of the change management process
• Applies skills and develops documentation including operating procedures, process flow charts and manufacturing procedures
• Documentation origination, editing and revision
• Creation of change request and associated paperwork utilizing the Electronic Document Management System (EDMS)
• Uses various computer software applications to complete assigned work activities
• Understanding of compliance requirements and regulations Ability to generate report(s) utilizing the systems
• Work with teams to determine status of projects/document changes and assist with driving project/document changes to completions
• Be able to develop and speak to metrics and workload tracking
• Be actively engaged in meetings
• Participates in the development of solutions to Quality System problems and/or non-compliance.
• Assists in maintenance of department, site / business unit, and corporate procedures and policies.

Required Qualifications

• Basic understanding of regulations.
• Advanced language proficiency in reading, writing, understanding, and communicating in English.
• Attention to detail.
• Intermediate computer skills and software applications, including experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint)
• Intermediate organizational and administrative skills
• experience in working in a cross-functional team environment as well as the ability to function independently
• Ability to gather and organize information
• Ability to grasp technical terms, processes, and methods
• Ability to handle a variety of projects at the same time
• Ability to prioritize and organize a busy and changing workload
• Ability to work in a team enviroment and/or independently with little supervision
• Works collaboratively with a variety of people at all levels within the organization to ensure effective communication and success of key initiatives
• Resolve problems by clarifying issues; researching and exploring answers and alternative solutions; implements solutions; escalates unresolved problems
• Ability to be flexible in work schedule, including a willingness to work overtime as needed
• Positive and Professional attitude