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Quality Assurance Specialist II

Technical Source
Raleigh, NC, United States
Full-time

Technical Source is looking for a Quality Assurance Specialist II to join our Pharmaceutical Client's Manufacturing team here in the Raleigh area!

This person will need to be someone who can be responsible for reviewing batch reports and releases for material,minor deviations, change controls, reviews & approval of SOPs.

We need someone who has been in a similar environment and similar role for at least 3 years!

Responsibilities :

  • Perform Activities related to Batch review and document in various systems (LIMS, SAP, etc.)
  • Ensure site compliance with regulations, ISO Standards, & Corporate / Local SOPs
  • Review and approve minor changes and deviations to provide guidance to departments regarding quality & related activities
  • Participate in process confirmations & quality oversight

Qualifications :

  • Understanding of cGMP manufacturing & Production processes
  • Minimum of 3 years of QA or related experience in the pharmaceutical or medical device industry
  • Ability to assist with equipment or supplies as needed
  • 23 days ago
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