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QC Technician

Durham, NC 27713

Posted: 09/11/2023 Employment Type: Contract Job Category: Scientific Job Number: 585388 Is job remote?: No Country: United States

Job Description

Job Profile Summary

The Coordinator, Quality Control Sample, provides sample control support at a Manufacturing facility. Job Description Responsibilities:
  • Create sample tracking and inventory system to track development samples
  • Administration of QC in-process, release, and stability samples, associated document coordination, and collection of data. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, personal development, and support of investigations.
  • May support the Manager for activities related to training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions.
  • Generate sample submission forms for various testing facilities
  • Collect sample forecasts to ensure lead time notice
  • Confirm testing was complete when sample invoices arrive
  • Follow/track international shipments, and alert logistics group of any customs clearance issues
  • Inspect incoming sample shipments and take necessary actions if samples do not comply with SOPs
  • Review and evaluate temperature data reports from temperature monitoring devices included with sample shipments
  • Create equipment, inventory, and sample receipt and tracking logbooks
  • Draft sample management procedures
  • Communicate with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
  • Write and revise documents such as SOPs and technical reports.
  • Other related duties as assigned.

  • Associates Degree in scientific field and 2 years of related experience in a GMP Quality Control laboratory., B.A. or B.S. in microbiology or related scientific field preferred.
  • Excellent oral and written communication skills with strong technical writing experience required.
  • Possess an understanding of the requirements of Sample Coordination in a GMP laboratory.
  • Ability to work effectively within the group, within Quality, and across the site.
Pay rates - $22.45-$44.25
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