- Novo Nordisk Inc. (West Lebanon, IN)
- …Performs walk-through audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by Manager, Quality ... and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch...pharmaceutical or biotechnology company with one (1) year direct Quality Assurance experience Knowledge, Skills, and Abilities:… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Will be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and support records to ... compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... Biotech is seeking a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role OverviewThe QA Shop Floor… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …review and drug product release practices.Develop positive relationships with the QA team, Quality Control, Information Technology, maintenance, Manufacturing ... in the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the... Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role OverviewThis exempt-level… more
- Tris Pharma (Monmouth Junction, NJ)
- …honest communications to help support individual and team success. Our Method Validation Department located in our Monmouth Junction, NJ headquarters has an ... immediate need for an experienced Method Validation Scientist II.Summary: Under supervision, performs laboratory analyses of raw materials, in process (IP), finished… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …industry practicesStrongly interface with Operations Department and other supporting groups (Engineering, Quality Control, Quality Assurance and other as ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Validation Technician, Aseptic Process as part of the Technical Operations team based… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for Daiichi Sankyo by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. ... or More Years First-hand knowledge of GAMP5, GxP and Non-GxP computer system validation and qualification and Computer Software Assurance (CSA), SDLC related to… more
- Merck & Co. (Rahway, NJ)
- …will play a pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including ... goals and metrics for the team to drive excellence.Device Quality OversightOversee the quality assurance ...processes (Design Control per ISO 13485, QMSR, Part 4).Lead quality oversight of product validation , verification, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing complianceKnowledge of cGMP regulations and ... OverviewThis position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy… more
- Aequor (Thousand Oaks, CA)
- …cross-functional program team. Works with the system, subsystem/platform, supply chain, service, QA , RA, Research project leaders to deliver quality products on ... to ensure projects deliverables are completed on time and adhere to high quality standards.Scope includes a wide range of devices, such as; needle protection… more
- BioAgilytix (Durham, NC)
- …budget.Workstream Coordination: Manage all internal BioAgilytix teams (lab operations, IT, quality assurance ) and external resources to ensure efficient project ... CFR Part 11, with a focus on data integrity and validation .Post-Implementation Optimization: Provide ongoing support and lead continuous improvement initiatives to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with other functions including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA , Reg CMC, and IT. This individual ... other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities according to the Software Development Lifecycle (eg commissioning test… more
- Genmab (Plainsboro, NJ)
- …of field target lists by partnering closely with BIA & Data Science.Manage quality assurance in the tracking & implementation of field force targets ... and finance.Proactively monitors and strives to maintain high levels of quality , accuracy, and process consistency in the sales organization's planning efforts.Lead… more
- Federal Reserve Bank (Philadelphia, PA)
- …together in a flexible work environment where you can truly find balance. The Software Quality Assurance ( QA ) Engineering Supervisor will lead and deliver ... is required. **Operations QA Engineering Supervisor** will focus on Software Quality Assurance (SQA) Operations and Engagement Management. You will lead a… more
- Fujifilm (Thousand Oaks, CA)
- …compliance of cGMP systems with all internal Quality requirements. **External US** ** QA Computerized Systems Validation (CSV) Specialist** The QA CSV ... and commercial phase cellular therapy company. **Reports to:** Associate Director, QA Validation **Location:** Thousand Oaks, California **Travel:** Up to… more
- Astellas Pharma (Westborough, MA)
- …Medicine (AIRM)** site in **Westborough, MA.** **Purpose:** The Validation Specialist, Quality Assurance , will provide QA oversight of commissioning, ... **Senior Validation Specialist, Quality Assurance **...to, the following:** + Individual Contributor responsible to execute QA Validation Strategy for clinical and pre-commercial… more
- Citigroup (Queens, NY)
- …engagement, and works to drives solutions / improvements. The role resides within the Quality Assurance Testing and Validation (QATV) group within the ... **The** **Conformance Testing - Fin Quality Assurance Manager** **, is a strategic professional who works to verify Citi's conformance to regulatory… more
- Citigroup (Tampa, FL)
- The Finance Quality Assurance Testing and Validation (QATV) function within the Finance Chief Operating Office (COO) organization is responsible for ... approval of risk associated with business changes. + Accountable for the quality , completeness, and accuracy of the implementation of the Control Framework,… more
- Fujifilm (College Station, TX)
- …reports, computer automation validation protocols and final reports and discrepancies for Quality Assurance . The QA Compliance Specialist III, QA ... representing a source of pride for the area. The QA Specialist III, QA Validation ,...of Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems, engineering… more
- Fujifilm (College Station, TX)
- …representing a source of pride for the area. The Quality Assurance ( QA ) Manager, QA Validation , will be responsible for the review and approval ... of commissioning/qualification/ validation protocols, reports, and discrepancies. The Manager will handle all associated responsibilities in compliance with FUJIFILM… more
