Quality Document Control Specialist - Urgent Need

Job Description

Works within the designated QMS element in accordance with process and procedural requirements.

Participates in meetings and escalations.

Participates in investigations.

Participates in regulatory compliance audits and inspections.

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

Accountable for the execution of specific tasks with moderate discretion and with oversight from a supervisor

Introduces or revises Quality system element procedures to maintain or achieve compliance to new or revised regulatory requirements at the direction of Quality management.

Essential / Key Job Responsibilities

• Works within the designated QMS element in accordance with process and procedural requirements.
• Participates in meetings and escalations.
• Participates in investigations.
• Participates in regulatory compliance audits and inspections.
• 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

Required Qualifications

• Advanced language proficiency in reading, writing, understanding, and communicating in English.
• Attention to detail.
• Intermediate to advanced computer skills and software applications, including experience with Microsoft Office tools (Outlook, Word, Excel, PowerPoint)
• Intermediate to advanced organizational and administrative skills
• Basic understanding of regulations
• Ability to organize and analyze data and identify trends to offer solutions.
• Experience in electronic document management system, i.e., MasterControl
• Ability to prioritize and organize a busy and changing workload

Preferred Qualifications

• Basic working knowledge of the regulations.
• Prior quality systems, manufacturing, laboratory, or product development experience.

Experience

• 1 – 3 years relevant experience

Physical Demands

• While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment.
• The employee frequently is required to talk and hear.
• The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.