JVT Advisors

Quality Documentation Specialist

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Location: Norwood, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length:  6 months

Job Summary:  The individual in this role will be responsible for providing Quality Assurance (QA) Documentation support for the company’s External QA team.

 

Responsibilities:

  • Review, approve and archive certain documents into the quality management system
  • Collect, record and archive documents in support of the external QA team
  • Report on pending documents and help support retrieval of hard copy documents needing archiving
  • Provide any other documentation support needed to ensure External QA is audit ready
  • Track Quality Systems including Change Controls and Deviations within the company’s systems as well as at CMOs

Requirements:

  • BS in a scientific or engineering discipline
  • Minimum 4 years’ experience in pharmaceutical / biotech industry within Quality Assurance or Quality (Assurance) exposure
  • Outstanding / effective communication skills (verbal and written)
  • Ability to manage multiple projects in a fast-paced environment
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment
  • Experience in the drug manufacturing and/or drug packaging and labeling processes
  • Experience in SAP or similar ERP system
  • Strong experience in Quality Document Management Systems including records and quality events
  • Proficiency in Microsoft Office tools including Powerpoint, MS Project and Visio
  • Previous experience in a GMP environment is required

 

Trevor Hoffman

Technical Recruiter

Trevor recruits for JVT's Life Sciences and Technology Practices where he specializes in finding, screening, and placing top-tier industry innovators at companies across multiple markets and verticals.

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