What are the responsibilities and job description for the Quality Document Control Specialist - Urgent Need position at MillenniumSoft Inc?
Position : Quality Document Control Specialist
Location : Mannford, OK
Duration : 12 Months
Total Hours/week : 40.00
pay rate-$20-25/hr
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
Location : Mannford, OK
Duration : 12 Months
Total Hours/week : 40.00
pay rate-$20-25/hr
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
- 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., MasterControl
- 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.
Salary : $20 - $25