Catalent Biologics
Pharmaceuticals
SpecialistI,QualityAssurance,ClientQuality
“Specialist I, Quality Assurance, Client Quality at Catalent Biologics. Skills: Quality Assurance Operations, Client Quality, Regulatory compliance. Represent Quality Assurance in support of Deviations. Represent Quality Assurance in support of Change Controls”
Industry & Context.
Problem resolution
What They're Looking For.
Must Have
Doctorate Degree in STEM discipline, Master's Degree in STEM discipline, Bachelor's Degree in STEM discipline, Associates Degree in STEM discipline, minimum of 0 years related experience, minimum of 4 years related experience, minimum of 6 years related experience, minimum of 10 years related experience, Ability to use Excel, Word, and other office systems, Prior work experience with quality management software, Ability to independently apply CGMPs, Maintains data integrity and ensures compliance, Executes procedures of high complexity with high quality, Advanced understanding of pharmaceutical laboratory and/or production operations
What You'll Do.
Represent Quality Assurance in support of Deviations
Represent Quality Assurance in support of Change Controls
Represent Quality Assurance in support of CAPAs
Participate in investigation
Participate in evaluation
Participate in problem resolution
Lead continuous improvement projects
Review Master Batch Production Records
Review material specifications
Oversee control and management of Cell Bank inventory
Review and approval of protocols
Review and approval of executed reports
Review and approval deviation investigation records
Provide training to Quality Assurance personnel
Provide training to Manufacturing personnel
Provide consultation and guidance for Manufacturing personnel
Support direct quality assurance oversight of manufacturing operations
Issue controlled documents
Review executed CGMP documentation
Disposition prepared solutions and columns
Notify Management of potential quality or regulatory issues
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Quality Assurance Operations department; Manufacturing personnel
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