Document Control Specialist

3 weeks ago

Fort Worth, United States Randstad Life Sciences US Full time

Job Details:

Technical Writer / Document Control Specialist in Forth Worth, TX

Duration: Contract (6 to 12 months +) possibility to go perm

Shift: 1st shift, M thru F, 8 am - 4:30 pm, some weekend work may be required depending on the manufacturing


Summary / Objective:

This role is responsible for the creation and review of technical documents, including SOPs, equipment documentation, and other supporting materials. Additionally, this role is responsible for issuing and managing document change controls to ensure efficiency and compliance.


Essential Functions:

  • Interact with technical associates, leads, and subject matter experts (SMEs) from other departments and divisions to create and revise GMP Manufacturing Batch Records, investigations, and change controls with a strong emphasis on liquid and solid dose manufacturing and packaging.
  • Prepare, write, update, and maintain manufacturing batch records, SOPs and FORMs where applicable, including the preparation of any forms or attachments that may accompany the SOP.
  • Other duties as assigned.


Required Core Competencies:

  • Effective skills in all areas of communication, collaboration, and decision-making.
  • Great attention to detail with the ability to work on multiple projects.
  • Work effectively with minimal supervision / independently with a sense of urgency.
  • Must be able to articulate their ideas clearly and concisely through effective written communication.
  • Must meet deadlines.
  • Strong organizational skills are essential, with a proven ability to manage and track multiple projects simultaneously while adapting to shifting priorities.
  • The ability to follow up with multiple departments is required.
  • Ability to create standard operating procedures as well as other supporting documentation, as needed.


Minimum Education/ Experience:

  • Degree (BA/BS) in a technology-related field (Biology, Chemistry, Pharmacy, Engineering, etc.).
  • At least 2-5 years of technical writing experience years in a cGMP manufacturing environment.
  • A strong command of the English language is essential. Ability to accurately convey information in both spoken and written form.
  • Computer experience is required. Proficiency in Microsoft Office (Word, Excel, and Outlook) is a must.

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