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Kelly Services has an outstanding Long-Term Temporary Administrator opportunity with a global medical device company in Warsaw, IN.JOB DESCRIPTION:Position: Operations technician (Hold, NC & CAPA) AdministratorREPORTS TO: VALUE STREAM MANAGERPRINCIPAL DUTIES AND RESPONSIBILITESAdministrative duties supporting the value stream supervisors and includes but are not limited to the facilitation of and monitoring of information relative to holds, problem statements, root cause analysis, corrections, corrective and preventative actions, tracking of time lines, and establishing/tracking/reporting Holds, Non-Conformance Reports (NR’s) and Corrective Action Preventive Action (CAPA) files.
Serve as a Value Stream point of contact in NR & CAPA regulatory/compliance.
Monitor the effectiveness of the NR & CAPA system for assigned value stream.
Serve as the coordinator of the CAPA meetings.
Trend CAPA metrics and present defined reports at specified intervals.
Present CAPA information during Value Stream and Management reviews.
Assist/Interface with CAPA owners on CAPA Investigations and Action Plans.
Ensure activities take place in a timely manner and in compliance with FDA 21 CFR Part 820, ISO 13485:2016, and other applicable global Company Quality System Regulations.
Expected Areas of Competence
Familiarity with good Manufacturing Practices and QSR/ISO regulations.
Familiarity with all aspects of modern quality control/assurance techniques such as, non-conformance reporting, corrective/preventative action plans, root cause investigations.
Detail oriented.
Excellent time management skills and organization skills.
Familiarity with computer usage and application such as (Compliance systems, PowerPoint, Excel)
Ability to exercise good judgment in determining the reasonableness of actions.
Ability to work with minimum supervision.
Innovative with the ability to make sound suggestions for improvement.
Possess effective presentation and writing skills.
Education/Experience Requirements
Energetic, team-oriented, and strong communication skills Quality-focused, attentive to detail and results-oriented Ability to identify root cause of problem, and creatively problem solve to gain resolution.Associates degree is preferred. High School diploma and a minimum of four years of experience as a quality technician, auditor, administrative or related roles, or a combination of education and experience.Pay rate: $20/hr.Monday through Friday 7:30-4:00 PMWhy Kelly ® ?Why Kelly ® ?At Kelly Services®, we work with the best. Our clients include 95 of the Fortune 100™ companies, and more than 70,000 hiring managers rely on Kelly annually to access the best talent to drive their business forward. If you only make one career connection today, connect with Kelly.AboutKelly Services ®As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
