Contract Document/QA Specialist

Contract Document/QA Specialist

Contract Document/QA Specialist

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Accentuate Staffing is currently recruiting for a Contract Document/Quality Assurance Specialist position with an established biotechnology organization in RTP. The ideal candidate will have previous experience working in a pharmaceutical or biopharmaceutical environment. This opportunity could lead to a permanent position and is looking for someone with a Document Control background.

Responsibilities:

  • Interpret and comply with quality assurance standards
  • Ensure adequacy of current quality assurance standards and recommend enhancements
  • Document quality assurance activities, including, internal audits and CAPAs
  • Identify and organize statistical quality data
  • Identify quality areas for improvement
  • Report on results of quality activities
  • Carry out appropriate corrective procedures from internal and external audits
  • Ensure risk management procedures are utilized correctly
  • Ensure ongoing abidance by industry regulatory and quality requirements

Requirements:

  • Bachelor’s degree in a scientific or technical related field
  • 5+ years of relevant Document Control experience in the pharmaceutical, biotech, bio-pharmaceutical or similar industry in a cGMP environment
  • 3+ years of proficient experience using an eDMS, MasterControl preferred
  • Proficient in Microsoft Office
  • Proficient in using eDMS systems such as MasterControl, TrackWise and SAP

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