Quality Document Systems Specialist ; Entry Level

Position: Quality Document Systems Specialist

Location: Mannford, OK

Duration: 12 Months

Total Hours per week: 40.00

Shift: 1st Shift (8am-5pm CST Monday through Friday)

Client: Medical Device Company

Job Category: Quality

Level of

Experience:

Entry-Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

• 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)
• AA degree required

• 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.
• Other duties and projects, as assigned.

• 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., Master Control
• Ability to prioritize and organize a busy and changing workload

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

• 1 - 3 years relevant experience

• 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.