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Quality Assurance Auditor 1

Req ID #: 219153

Newark, Delaware, USA

About this job

The Microbial Solutions team at Charles River Labs is seeking a Quality Assurance Auditor at our site in Newark, DE.

The Microbial Solutions team at Charles River Labs is seeking a Quality Assurance Auditor at our site in Newark, DE. 

The hours for this position are Monday - Friday 1000- 1830 Eastern Time Zone hours. 

This position requires flexibility and the ability to work overtime to support business needs. 

Basic Job Summary

The QA Auditor will perform final review of basic records, reports, and inspection of sampling processing as well as conduct final release in compliance with applicable regulatory requirements, and corporate policies and procedures.

Essential Duties and Responsibilities 

  • Review and approve test results.
  • Perform QC release of specified reagents and raw materials.
  • Report all quality control issues, including but not limited to: OOSs, deviations, observations affecting processes, consumable/ vendor quality, equipment calibration, and training issues to the Quality Manager.
  • Collect and organize data for all laboratory investigations.
  • Collect and organize laboratory validation data.
  • Provide technical support for internal audits.
  • Maintain laboratory safety standards and requirements.
  • Adhere to all laboratory SOPs.
  • Participate in internal facility/SOP procedural audits to obtain a clear understanding of the Quality System and regulatory requirements for the testing operations.
  • Recommend and implement improvements for procedures and protocol.
  • Adopt work procedures and processes that support company and departmental standards, procedures, and strategic directives.
  • Participate in associated GMP training to obtain an understanding of GMP regulations and site SOP requirements.
•    Perform all other related duties as assigned.

CRL site

About Charles River

Charles River is an early-stage Contact Research Organization (CRO). Here, we are passionate about our role in improving the quality of people's lives. With 100 sites around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients' unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

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