Quality Control Specialist [Must have Document Control]

MillenniumSoft Inc; Mannford (OK); On-site; USD 42,000 - 52,000; Full time

Job summary

MillenniumSoft Inc in Mannford, OK is seeking a Quality Control Specialist with docu ment control experience for a 12+ month contract. The role is 40 hours/week on site, with a 8am-5pm CST schedule.

Requires AA degree and background in regulated industries (medical device, manufacturing, healthcare). Strong proficiency in MS Office and EDMS tools; familiarity with MasterControl is a plus.

Qualifications

• Must have experience in quality control, quality assurance, and QMS in regulated industries.
• Must have Document Control experience (or writing SOPs, etc.).
• AA Degree required.

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
• 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 EDMS
• Uses various computer software applications to complete assigned work activities
• Understanding of compliance requirements and regulations; Ability to generate reports
• Work with teams to determine status of projects/document changes and assist with driving project/document changes to completions
• Develop and speak to metrics and workload tracking
• Be actively engaged in meetings
• Accountable for the execution of specific tasks with moderate discretion and oversight from a supervisor
• Introduce or revise Quality system element procedures to maintain or achieve compliance to new or revised regulatory requirements
• Other duties and projects, as assigned.

Skills

Quality control

Quality management systems

Quality assurance

Quality technician

Education

AA degree

Tools

MasterControl

Job description

Job Title - Quality Control Specialist [Must have Document Control]

Location - Mannford, OK

Duration - 12+ Months Contract

Total Hours/week - 40.00

pay rate-$20-25/hr

1st Shift

Client: Medical Device Company

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

Interviews will be by video chat

Onsite position

• 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

Be part of something bigger!

Client is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

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.