Job Details

Documentation Control Specialist

  2026-03-07     Astrix Technology     Roanoke,VA  
Description:

Documentation Control Specialist

Quality Assurance

Roanoke, Virginia, US

  • Added - 04/03/2026

Pay Rate Low: 20 | Pay Rate High: 25

Job Summary

The Quality Documentation Coordinator manages important quality documents in a regulated (cGMP) environment. This includes organizing, tracking, storing, and retrieving records like batch records, test results, and Certificates of Analysis.

Key Responsibilities

  • Organize, track, file, and retrieve quality documents (both electronic and paper)

  • Review batch records and Bills of Materials (BOMs)

  • Send first production samples to customers and prepare shipping paperwork (FedEx/UPS)

  • Release or place finished goods on hold in the ERP system (e.g., Access)

  • Track and share documents with customers

  • Help prepare quality issue reports

  • Maintain safety records and ensure compliance with safety and cGMP standards

  • Support audits and inspections by providing requested documents

  • Identify documentation issues and help fix them

Qualifications

  • High School Diploma or GED (required)

  • 1-3 years of relevant experience in documentation, manufacturing, or quality assurance (preferably in a cGMP-regulated environment) (Preferred)

  • MUST have knowlege of FDA documentation

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.


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