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Specialist Quality Control

Holly Springs, IL 27540

Posted: 01/22/2025 Employment Type: Contract Job Category: Quality Job Number: 4223

Job Description

Under general supervision, this position will perform tasks associated with establishing routine procedures, and defining business process in support of the QC Sample management group.

Responsibilities:
  • Assist with procurement activities for consumables and critical reagents for lab start up.
  • Support the startup and qualification/validation of the Sample Management and Stability Laboratories in a GMP environment.
  • Assist with establishing the processes and procedures for sample handling and storage.
  • Develop/Perform routine Sample Management laboratory procedures:
  • Sample Manufacturing Sweeps
  • Aliquot cGMP samples
  • Manage Sample Shipments
  • Contract Testing Laboratory (CTL) Management
  • Maintaining and operating specialized equipment as applicable
  • Initiating and / or implementing changes in controlled documents.
  • Support routine activities over the weekends and public holidays as required.
  • Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory log books (as applicable).
     
Requirements / Qualifications:
  • Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
  • Ideal candidate must be familiar with documenting tasks within LIMS.
  • Sample Management lab experience is required.
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