732-661-0400

Document Control Specialist

  • Location: Houston, TX
  • Type: Direct Hire
  • Job #35298

Document Control Specialist

Direct Hire!
9-5 hours, Monday – Friday
Salary: $50K-$58K

Position Overview

As a Document Control Specialist, you will be part of a Document Management group working with a team of professionals focused on improving and saving lives by developing treatments for cancer.

This position will be required to work collaboratively with all departments to manage and maintain controlled documents within the company’s quality management system. This position will require expertise in Microsoft Word and Excel as well as PDF automation tools in Adobe Acrobat Professional. Attention to detail and organizational skills along with ability to operate independently, collaborate with all departments and manage competing priorities and timelines are also important. This position reports to the Senior Manager of Quality Systems.

Position Responsibilities
 

  • Facilitate the implementation of the document management system to ensure optimal operation for all personnel
  • Assist the System Administrator in performing the daily functions within the electronic document management system
  • Perform a visual quality check of each document and validate the correctness of formatting, styles and compliance with company standards.
  • Provide publishing support for company documents, including the use of eCTD format for regulatory submission documents
  • Assist in managing and tracking non-conformance events, deviations, CAPAs in the electronic QMS.
  • Document and track Change requests as they are initiated for all regulated changes to the quality system.
  • Create training courses and manage training activities for all personnel in the electronic QMS
  • Maintain the standards of ethical behavior and conduct to promote a quality culture with the organization and ensure the safety and reliability of product.
  • Work independently, with support through management and mentoring
  • Perform other duties related to improvement of quality systems as needed and required by management

Skills, Education And Experience Required
 

  • Associates or Bachelor’s degree
  • Minimum of 2-3 years of experience in document management in the Pharmaceutical industry
  • Working knowledge of GMPs in conformance to U.S. standards (21 CFR 210/211, 1271 and 810).
  • Experience with Change Control practices/strategies
  • Ability to work both independently and be a part of a team, able to work with minimal direction and adjust workload based upon changing priorities.
  • Proficient in Outlook, MS Word, Excel, Power Point, Adobe Acrobat Professional and other software applications

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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