- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description:The Rahway based Senior Specialist , Global Development Quality Operations, is responsible for independent approval of ... Control, Process Improvements, Quality Assurance Systems, Quality Risk Management, Technical Writing, Validation Processes-Preferred Skills:Job Posting… more
- Catalent Pharma Solutions (Kansas City, MO)
- ** Senior Validation Specialist I, BioAnalytics Computer System Validation (CSV) & Compliance** **Position Summary:** Catalent, Inc. is a leading global ... Solutions in Kansas City, MO (KCM) is hiring a Senior Validation Specialist I, BioAnalytics...QA ) and internal Business Units (Manufacturing, Pharmaceutics, Analytics, Quality Control) to successfully manage all assigned CSV program… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated ** Senior Validation Specialist - CSV** to ensure compliance of computerized systems with regulatory ... Part 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical...well as deviation notifications/investigations + Collaborating with IT, Automation, Quality Assurance and End Users to ensure… more
- Curia (Rensselaer, NY)
- Senior QA Validation Specialist -...Services, R&D, Production, Maintenance and QA /QC in Validation and Quality Assurance -related issues. ... CSV Systems Engineer Summary: The Senior Validation Specialist , assists with the validation...concepts and approaches with audits and inspections + Provide Quality validation review and approval through the… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- Our Fill Finish QA Validation team is hiring. As the Senior QA Validation Specialist , you will ensure equipment, systems, and processes meet ... + Presents project and program status and metrics to Senior Management. Act as Technical Subject Matter Expert (SME)...and the following years experience for each level: + QA Validation Specialist : 2+ years… more
- Genentech (Boston, MA)
- …with regulatory-aligned digital data or platforms + Exposure to annotation workflows, data quality assurance , or ML-based validation methods + Experience ... of Roche medicines. **The Opportunity:** As a Data Strategy, Annotation, and Validation Specialist within the Digital Endpoints and Patient-Centered Solutions… more
- Guidehouse (Bethesda, MD)
- …and policies (eg, in response to CLIA88 or CAP) involving staffing, training, quality assurance /improvement ( QA /I) approaches and reports and preparation for ... proficiency testing (PT) monitoring (not just PT test performance); instrument/method calibrations, validation and QC monitoring, quality assurance indicator… more
- Merck (Rahway, NJ)
- **Job Description** **Job Description:** The Rahway based ** Senior Specialist , Global Development Quality Operations** , is responsible for independent ... Control, Process Improvements, Quality Assurance Systems, Quality Risk Management, Technical Writing, Validation Processes **Preferred Skills:** **Job… more
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. **Summary** The Senior Specialist , External Manufacturing Quality Assurance is responsible for ... policies, standards, procedures and global current Good Manufacturing Practice (cGMP). The Senior Specialist provides Quality support and oversight for… more
- Bristol Myers Squibb (Indianapolis, IN)
- …the global leader in radiopharmaceuticals. **Summary** The Senior Specialist , QA Operations will help support operations through quality oversight in a ... Radiopharmaceutical facility in Indianapolis, IN. The Senior QA Operations specialist will...material and batch disposition activities. This position will utilize quality assurance knowledge in ensuring compliance in… more
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