Quality Control Specialist Document Control

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

Location – Mannford, OK

Duration – 12+ Months Contract

Total Hours/week – 40.00, 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, etc.)
• AA Degree Required

• Work within the designated QMS element in accordance with process and procedural requirements.
• Participate in meetings and escalations.
• Participate in investigations.
• Participate in regulatory compliance audits and inspections.
• Complete 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.
• Report changes to both internal and customer management teams.
• Identify and drive continuous improvements to the quality and efficiency of the change management process.
• Apply skills and develop documentation including operating procedures, process flow charts and manufacturing procedures.
• Document origination, editing and revision.
• Create change requests and associated paperwork utilizing the Electronic Document Management System (EDMS).
• Use various computer software applications to complete assigned work activities.
• Understand compliance requirements and regulations; generate reports utilizing the systems.
• Work with teams to determine status of projects/document changes and assist with driving project/document changes to completion.
• Develop and speak to metrics and workload tracking.
• Be actively engaged in meetings.
• Be 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 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 with an 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.

• Regularly required to stand, walk, sit and use hands to manipulate, handle, or feel objects, tools, controls and office equipment.
• Frequently required to talk and hear.
• Occasionally required to reach with hands and arms and stoop, kneel or crouch.