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1+ months

Electronic Document Specialist

Kelly Services
Summit, NJ 07901
**Title:** Electronic Document Specialist



**Location:** Summit, NJ 07901



**Duration:** 6 months contract; possibly longer for the right candidate



**Compensation:** Up to $25.00 per hour; Depending on experience





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




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



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**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.

\#KellyGTS
Posted: 2020-08-19 Expires: 2020-09-19

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Electronic Document Specialist

Kelly Services
Summit, NJ 07901

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