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5 days old

Document Control Specialist

Kelly Services
Irvine, CA 92604
**Document Control Specialist**


Kelly Services is currently seeking a Document Control Specialist for a long-term engagement with one of our clients in Irvine, CA.


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


Summary: Responsible for ensuring documents submitted with changes conform to established standards and providing support to the Document and Change Control process.


This position is located in an office environment and requires frequent meetings and working for extensive periods on a computer.


Responsibilities:


+ Develop processes and structure for the information flowing into and out of the database.

+ Identify opportunities for improvement for future growth.

+ Manage the resources needed to achieve project goals.

+ Identify and resolve issues and conflicts within the project team.

+ Proactively manage changes in the project scope, identify potential issues, and devise contingency plans escalating as appropriate.

+ Establish the process of company integration into the database and provide oversight of the day to day operations.

+ Support the entity integration around the world.

+ Maintain good relationships with Regulatory Authorities, Regulatory Departments and distributors and provide support to worldwide partners.

+ To control expenditure within assigned budget.

+ Problem resolution of business partner concerns and project constraints.


Requirements:


+ Bachelor degree or equivalent experience

+ 2+ years of experience in medical device manufacturing industry

+ Quality Assurance/Systems experience preferred

+ Strong computer skills and use of software applications, including Microsoft Windows and Office applications (i.e., Word, Excel, PowerPoint, etc.)

+ Knowledge of general medical device requirements is a plus

+ Ability to work under pressure in a dynamic, fast-paced environment

+ Ability to multi-task and interact well with others

+ Good attention to detail


Preferred Qualification:


+ Experience on Microsoft Access

+ Demonstrated problem-solving skills

+ Experience with electronic PLM systems


Job Details


+ Location: Irvine, CA

+ Pay Rate: $24+/hour (depending on experience)

+ On-site 3 days per week // Remote 2 days per week


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-11-22 Expires: 2021-12-23

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Document Control Specialist

Kelly Services
Irvine, CA 92604

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