**Job Title:** QA Operations Specialist
Base title: QA Operations Specialist
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About the Role
This is a critical position that plays a pivotal role in ensuring compliance and execution of site operational activities. As a key partner to stakeholders, the successful candidate will report directly to the Rathdrum Site Quality Operations (QO) Lead.
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Key Responsibilities:
* Ensure Compliance: The ideal candidate will ensure that the process for Active Pharmaceutical Ingredient manufacture complies with cGMP and regulatory requirements.
* Quality Oversight: Provide quality oversight and support for operations in manufacturing, testing, packaging, and material management.
* Review and Approval: Review and approve batch records, cleaning records, and Master Batch Records (MBR).
* Quality Reviewer: Quality reviewer of SOPs, EOPs, Change Requests, Protocols, Reports, etc.
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Requirements
* An undergraduate degree in pharmaceutical, biological, or chemical sciences.
* A relevant advanced degree is preferred.
* A minimum of 5 years of relevant experience in the Pharmaceutical and/or Animal Health industry, with current knowledge of cGMP's and regulatory guidance required.