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Quality Assurance Specialist

Raleigh Metro Area, NC

Post Date: 01/17/2018 Job ID: JN -012018-20749 Job Type: Scientific
Description:
Supports the batch disposition team documentation through processing of batch records, generation of lot release protocols, facilitating SOP revisions, and assisting with raw material release processing. These activities will be completed ensuring compliance with cGMPs, site SOPs, and regulatory requirements.
Major Accountabilities
  • Compiles lot release protocols for primary and secondary manufacturing
  • Interacts with support departments to ensure quick and effective issue resolution
  • Review and update the batch status tracker on a daily basis
  • Receipt and processing of batch production records; receiving, assigning, and archiving
  • Scanning and review of raw material documents to support release functions
  • Complete updates to QA Specs and other release SOPs as needed
Skills:
  • 3+ years experience in Quality Assurance and/or in aGMPregulated environment within the pharmaceutical industry or equivalent.
  • Must have strong interpersonal, written and oral communication skills
  • Prior batch release experience preferred
  • Strong computer skills
  • Ability to problem solve and ensure issue resolution

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