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Quality Assurance Associate

2 months ago

St Louis, United States Randstad Life Sciences US Full time

1 year Contract

St Louis, MO

PR: $17-22/hr



Key Accountabilities

The key responsibilities of a Quality Assurance Document Coordinator include the following:

  • Be responsible for the scanning and indexing of QC data and batch records into the SAP document retention software.
  • Evaluate and process new and revised document workflows in the electronic document management system. Verify and or assign approval panels on document workflows and ensure open workflows are completed in an acceptable timeframe.
  • Be responsible for the assignment of periodic review tasks to responsible department assignees and ensure periodic review workflow are completed.
  • Issue manufacturing, packaging, and labeling documents to manufacturing per the schedule. Interact with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
  • Works to ensure accurate and timely record archival of site batch records and other quality records, including imaging and physical record management and calibration records.

Scope of People Responsibility

  • This individual will work with various internal departments to develop, improve, and execute and process documents used in an ISO 9001 and ISO 13485 quality system environment and specific business-related initiatives.


Education

  • High school diploma or GED with 1-2 years applicable in a QA job function as deemed appropriate by QA Management.
  • Associate degree in Life Sciences, Chemistry, or other related subject or equivalent experience preferred.

Work Experience

  • Knowledge of ISO 9001:2008 and, ISO 13485 desired.
  • Knowledge of other regulatory requirements (i.e., USDA, FDA, EC, DEFRA, ICH, and EDQM) desired.

Job specific Competencies & Skills

  • Excellent computer skills, including proficiency in MS Word, MS Excel, MS PowerPoint, and ability to learn and operate other specific application software required.
  • Excellent communication (verbal and written), excellent writing skills and experience writing technical documentation and reports required and customer interface skills.
  • Experienced in using quality system applications such as Trackwise, Document Control, and/or ManGo.
  • Ability to follow written instruction to complete tasks accurately.
  • Knowledge of ISO 9001 and ISO 13485 regulatory requirements desired.

ADDITIONAL LOCAL NEEDS:

  • 100% Office Environment