Document Control Specialist

Smith & Nephew Pittsburgh , PA 15201

Posted 2 weeks ago

Job Description:

Job Summary:

The Document Control Specialist is a quality focused individual responsible for the coordination, execution and maintenance of the Document Control process according to approved procedures. The Document Control process controls the document lifecycle of QMS, DMR and DHF documentation.

This position will interact with functions including, but not limited to; Quality Engineering, Software Quality Engineering, Sustaining Engineering, Regulatory Affairs, Software, Mechanical and Electrical Engineering, Manufacturing Engineering and the Project Management Organization.

Job Duties and Responsibilities:

  • Assess and recommend operational efficiencies of company's Document Control process.

  • Responsible for the electronic file maintenance of thousands of documents and records.

  • Must be able to provide high attention to detail and quality work while performing and reviewing documentation submitted.

  • Understand and enforce Good Documentation Practices according to the company's current procedure.

  • Accurate data entry and maintenance of all master data files.

  • Timely filing of meeting minutes and other records.

  • Accurate maintenance of Document Control files.

  • Address questions from peers interacting with the Document Control process.

  • Provide classroom training on Document Control processes.

  • Actively participate in internal and external audits and other activities covered under the Smith & Nephew Quality Management System as required.

  • Ability to work efficiently and effectively under tight deadlines and maintain high quality output.

Desired Job Experience:

  • 2 years or more in a regulated industry, medical devices preferred.
  • 2 years or more Document Control experience preferred.

Skills:

  • Highly proficient in Microsoft Office Products especially Microsoft Word and Excel.

  • Proficient at reviewing and editing documentation.

  • Continuous improvement and quality mindset.

  • Willingness to develop yourself and others.

  • Positive customer service attitude and focus.

  • Highly proficient in electronic file management utilizing windows explorer.

  • Ability to quickly learn new software based data and document management systems.

  • Effective planning and organizational skills with the ability to prioritize, multitask and work with a high degree of accuracy and attention to detail.

  • Strong verbal and written communication skills.

  • Ability to exhibit flexible thinking.

  • Knowledge of GMP's, FDA 21 CFR 820, ISO 13485 and other regulatory agency requirements sufficient to apply to quality operations and compliance.

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Document Control Specialist

Smith & Nephew