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24 days old

Clinical Electronic Document Specialist, Summit, NJ

Kelly Services
Summit, NJ 07901
**Clinical Electronic Document Specialist, Summit, NJ**



**Position Type: Contract (6-months)**



**Scope of Position:**



This position is responsible for supporting the CTDO Quality Systems Documentation Control group by coordinating activities related to GMP/GDP documentation systems and administrating associated SOPs and business processes that ensure compliance with established company/industry requirements.



**Duties and Responsibilities:**




+ Serve as a documentation system SME and provide guidance to system users as needed.

+ Serve as a Document Control Reviewer/Approver on documentation managed through the electronic GMP/GDP documentation management system

+ Prints/Issues Master Batch Records and Batch Record Related documentation

+ Prepares/Issues logbook and Quality Control Form requests

+ Assists with maintenance and administration of procedures related to job function

+ Systematizes and streamlines document workflows

+ Maintains training material for applicable document management systems

+ Provides end-user training on electronic document management systems

+ Works independently and has a direct impact on documents that are subject to regulatory authority inspection

+ Compiles applicable process metrics, identifies trends and escalates accordingly

+ Coordinates activities and projects with other functions, such as GMP Training

+ Ensures that documentation complies with established documentation system process/requirements

+ Provides support during internal and health authority inspections of facility

+ Monitors the periodic review process for documents

+ Communicates effectively with all cross functional and regional stakeholders on matters related to documentation systems

+ Distributes official documents to internal and external customers as needed

+ Works with team to implement records management policies and schedules for the electronic and physical records as needed

+ Carries out plans and actions in the documentation system to support acquisitions, new product launches, product in-license operations, new market and trading partner opportunities, and other quality management activities as assigned.

+ Supports Quality Systems harmonization efforts.

+ Performs other tasks as assigned



**Education and Experience:**




+ HS diploma or equivalent required. College or university degree preferred.

+ 3+ years of related Quality experience in the pharmaceutical or related industry

+ An equivalent combination of education and experience may substitute



**For Immediate Consideration, Apply Today! Questions? Call Grace at 714.253.7656 or schedule a time to connect directly follow the link:** https://calendly.com/gracepiper/15min-1






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



Kelly Science 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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-07-13 Expires: 2020-08-13

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Clinical Electronic Document Specialist, Summit, NJ

Kelly Services
Summit, NJ 07901

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