5/20/14 – QA Specialist II

Accentuate Staffing is currently recruiting a QA Specialist for a client of ours in RTP, NC.

Responsibilities

  • Maintain and assist document control workflows, to include: maintenance and development of associated policies, databases, master lists, and document management programs
  • Provide Records Management support, to include: importing records into electronic repositories, participating in Records Management clean-out days, and creating/maintaining indexes to track records and provide work metrics
  • Coordinate, assemble, and route documentation to support controlled document lifestyle requirements as directed by the Quality Systems Document Management policy
  • Perform data entry, record issuance, retrieval, audit/reconciliation, and archive support for QA programs
  • Provide support during internal audits

Requirements

  • Bachelor’s Degree in Science or Engineering and 3+ years of QA experience in the Biotechnology industry OR Associate’s Degree in Science or Engineering and 5+ years of QA experience in the Biotechnology industry
  • Proficient in Microsoft Office and Adobe Acrobat applications
  • Experience with Document, Records, and Information Management systems
  • Experience with cGMP Manufacturing Operations and Process Development is preferred
  • Experience with Enterprise applications (Master Control, LIMS, Trackwise, Documentum, SAP) is preferred
  • Ability to lift and/or move up to 25lbs and occasionally stand, walk, reach, and/or stop
  • Strong organizational, documentation, and problem-solving skills