Experience:
3-5 years of experience
Concerned about your lack of experience? Learn More...
Employment Type:
Full time
Posted:
11/1/2019
Job Category:
Administration
Document Specialist II
(This job is no longer available)
Vericel | Cambridge, MA
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Job Description

Position Summary:

Work with primary originators of documentation to ensure that documentation is written, edited, reviewed, and approved in compliance with cGMP.

Core Responsibilities:

* Process Document Change Requests (DCRs) and documentation status reports.
* Finalize controlled documents (masters) and maintain / distribute Official Copies.
* Contribute to (and occasionally identify) department improvement projects.
* Contribute to QADC SOP improvements and execute document revisions through eWorkflow System.
* Ensure GMP documentation is correct, clear, and consistent.
* Update and maintain workflows and various databases.
* Provide guidance to employees as needed.
* Ensure document formatting requirements are adhered to per departmental procedures.
* Perform data entry for tracking documents and departmental metrics.
* Develop and execute training to QADC and external departments on Document Systems.
* Prepare and manage data to be archived to off-site storage facility.
* Facilitate the Document Periodic Review Program.
* Maintain controlled documents in strict compliance to corporate policies and regulations.
* Facilitate the effective processing of Quality Systems documents to ensure they are maintained and archived in an organized and retrievable state for accountability and access for any regulatory body.
* Other duties as required.

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

* Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
* Being honest and treating people with respect and courtesy.
* Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
* Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

* High School Diploma or equivalent and 5+ years of related experience, or
* Associates degree or equivalent and 3+ years of related experience
* 2 years of GMP document control experience
* 1-2 years of MS Office Suite experience; MS Word - ability to create / modify templates, knowledgeable with styles formatting, hyperlinking and track changes functionality;

MS Excel - ability to generate spreadsheets with applied knowledge of formula creation and maintenance, charting and formatting
* Strong written and oral communication skills
* Time management skills
* Strong attention to detail

Preferred Qualifications:

* College degree or equivalent in related field
* Familiarity with working in a Document Management System (i.e. Livelink, Documentum, etc.)
* Technical writing experience

Working Conditions and Physical Demands:

* Ability to lift and carry up to 40 lbs
* May require holiday coverage