Analysis Skills, Biology, Business Solutions, Category Management, Communication Skills, Continuous Improvement, Cost Control, Customer Support/Service, Data Collection, Delivery Management, Management Strategy, Master Data Management (MDM), Negotiation Skills, Procure to Pay/Purchase to Pay (P2P), Procurement Specifications, Purchasing/Procurement, Requirements Management, Risk Analysis, SAP ECC (fka SAP R/3 and SAP ERP), Strategic Planning, Time Management, Vendor/Supplier Management, eSourcing
Description:
- Conduct quality control (QC) review, including verification of data against approved supporting documentation/sources for aggregate reports.
- Performs data integrity review of CMC data and reports intended for regulatory filings.
- Ensures integrity, accuracy, and consistency of data and documents.
- Record QC metrics per defined categories.
Major Requirements:
- BA/BS or equivalent with typically 3+ years relevant experience in a biotechnological and/or pharmaceutical Quality Assurance setting.
- Experience in a pharmaceutical development environment with knowledge and review experience on development study protocols and reports for investigational stage products.
- Excellent oral and written communication skills.
- Ability to perform and verify mathematical determinations utilizing both calculator and computer programs, such as MS Excel.
- Ability to work effectively in a matrix setting to resolve issues and achieve common goals
Preferred:
- Previous experience with cell therapy development or cell-based assays (technical or quality review).
Experience working under GxPs and/or knowledge of GMP, ICH, USP and global compendial regulations and guidance.
S
Software Galaxy Systems, LLC