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Document Control Specialist

1 month ago

Austin, Texas, United States Aston Carter Full time
Job Title: Document Control Specialist

Aston Carter is seeking a highly organized and detail-oriented Document Control Specialist to join our team. In this role, you will be responsible for managing and maintaining a wide range of documents, including lab notebooks, audit reports, SOPs, and training records.

Key Responsibilities:

  • Issue document numbers, part numbers, and project numbers
  • Process all document and drawing changes, including preparation, formatting, distribution, routing, maintenance, and release to authorized users
  • Process and maintain the manual/electronic routing, tracking, distribution, and retrieval of documents
  • Create and maintain bills of material using Agile
  • Perform document control activities, including assembling batch records, assigning tracking numbers, record filing, and lab notebook issuances
  • Maintain document filing systems and electronic databases for archived regulatory information
  • Assist with employee training and development of QA training materials
  • Assist with internal audits and assist with vendor/supplier audits
  • Assist in development of documentation (batch records, documentation supporting submissions)
  • May write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed
  • Prioritize projects appropriately and with flexibility to accommodate changing company objectives

Requirements:

  • Requires associates, prefers bachelors
  • Documentation, archiving, and records management (experience in regulated industry/medical device industry highly desirable)
  • Working knowledge of Agile database usage and change control process
  • Computer proficient in PC-based software such as Excel, MS Word, Access, PowerPoint, Portable Document Format (pdf), and Adobe Acrobat Writer/Distiller
  • Knowledge of ISO 9001:2000, ISO 13485:2003, and FDA QSRs

About Aston Carter:

Aston Carter provides world-class corporate talent solutions to thousands of clients across the globe. We specialize in accounting, finance, human resources, talent acquisition, procurement, supply chain, and select administrative professions. We draw on our deep recruiting expertise and expansive network to meet the evolving needs of our clients and talent community with agility and excellence.

We are proud to be a ClearlyRated Best of Staffing double diamond winner for both client and talent service. Diversity, Equity & Inclusion are embedded into our culture through hiring diverse talent, maintaining an inclusive environment, building a culture of care, engagement, and recognition, and ensuring growth opportunities for our people. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.