Senior QA Specialist leading quality assurance for client projects in a biopharmaceutical company. Driving compliance and facilitating client interactions to ensure effective quality systems.
Responsibilities
Serves as QA facilitator for the Quality aspect of client projects.
Provides interface between KBI Quality and client regarding batch status, Quality metrics, and Quality issues impacting batch disposition and disposition timeline.
Communicates client concerns to KBI teams; facilitates discussions as necessary to resolve client issues.
Supports Batch disposition, fully executing the disposition process as needed.
Supports audit / inspection readiness of the site.
Works with Global Compliance to support Client Audits
Requirements
BS/BA Degree in Science or Engineering relevant to the pharmaceutical / Life Science or related industries
Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Operations including solid knowledge of global GMP Quality and Regulatory requirements.
Minimum of 2 years of previous experience in QA and in a Client-Facing QA or Project Management role
Ability to communicate in customer-facing forums to progress issues and obtain positive results.
Minimum intermediate proficiency with of Microsoft Office Excel, Word, PowerPoint (Microsoft365).
Intermediate proficiency with ERP and QMS systems required, such as SAP, TrackWise, and LIMS
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