Quality Assurance Role Overview
This Quality Assurance Specialist position focuses on ensuring site operational activities meet compliance and execution standards at the Rathdrum Site.
* The specialist will collaborate with other stakeholders to ensure the site remains inspection-ready at all times.
This role encompasses quality oversight and support across manufacturing, testing, packaging, and material management. It also entails ensuring GMP activities align with regulatory, corporate, and site procedures.
Main Responsibilities
* Reviewing and approving batch records, cleaning records, and master batch records.
* Issuing batch records and cleaning records as needed.
* Conducting quality reviews of SOPs, EOPs, change requests, protocols, reports, etc.
* Participating in site tier meetings and internal audits/quality walkthroughs.
Requirements and Qualifications
* A Bachelor's degree in pharmaceutical, biological, or chemical sciences is required.
* Candidates should have 5+ years of experience in the pharmaceutical industry.
* Certification in LSS (Lean Six Sigma) is preferred but not mandatory.