Quality Document Systems Specialist - Urgent Need (Entry Level)

Job Description

Must have experience in quality (quality control, quality management systems, quality assurance, quality technician)

Must have experience in a regulated industry (medical device, manufacturing, healthcare, pharmaceutical, clinical trials, laboratory)

Must have Document Control experience (or technical writing, writing SOPs, grants, things like that)

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
• 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.

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.