QA Document Technician

Baltimore, MD 21230

Posted: 08/26/2019 Industry: Biotech/R&D/Science Job Number: 49442

Individual must have previous GMP experience.  Execution of tasks within the Quality Assurance department to support GxP activities, including reconciling, scanning, and archiving records, providing support during client and regulatory inspections. Individual will be taught skills in SAP for supporting management of Quality System documents. 

Experience with MS tools (i.e., Excel, Word, PowerPoint) and attention to detail is critical.

 

Responsibilities

Quality Assurance Support
  • Receive, paginate, scan, and archive compliance records.
  • SAP entry and data entry review.
  • Manage deviations as initiated (keep Excel spreadsheet current, assign criticality levels, keep SAP current, prepare metrics for monthly QMR)
  • Site Support
  • Support department and site projects and initiatives.
  • Fulfil internal customer requests requiring execution as assigned.
  • Regulatory Inspection and Client Audits
  • Provide campus support during regulatory and internal inspections of quality systems:
  • Act as a scribe during inspectin activity.
  • Advanced document preparation.
  • Document accountability to ensure a clear and concise record of information reviewed by clients/regulators is maintained and reconciled.

 

Education, Experience & Skills

Minimum Requirements

High school diploma or equivalent level of skills and experience.

> 2 years related experience.

Experience with the Microsoft Office product line including Word, Excel, Access and Project.

Experience with Adobe Acrobat.

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