Quality Document Control Specialist - Urgent Need

MillenniumSoft Inc
Mannford, OK Contractor
POSTED ON 5/28/2024 CLOSED ON 6/27/2024

Job Posting for Quality Document Control Specialist - Urgent Need at MillenniumSoft Inc

Position : Quality Document Control Specialist

Location : Mannford, OK

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

Client: Medical Device Company

Job Category: Quality

Level of Experience: Entry-Level

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

Shift hours will be 8am-5pm CST Monday through Friday

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)
  • AA degree required

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.
  • Other duties and projects, as assigned.

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.
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Estimate Salary for Quality Document Control Specialist - Urgent Need in Mannford, OK
$36.62 (Medium)
$31.60 (25th)
$41.65 (75th)
For Employer
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