Quality Control Specialist [Must have 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. Essential / Key Requirements 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 Essential / Key Job Responsibilities 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. 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 with an 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 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. #J-18808-Ljbffr MillenniumSoft Inc