- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary The GMP Quality Assurance Internship is a program that provides training for the intern in the ... field of pharmaceutical Quality Assurance focused on the activities related to the overseeing...of GMP QA Department such as Audit, Quality Management System , Pharma Product, External Supplier Management and Strategical Operations… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document Control ... dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel,… more
- Merck & Co. (Durham, NC)
- … System Model and relationships across its componentsUnderstands quality systems relevance and importance when developing quality policies, SOPs and ... Job DescriptionOur Quality Assurance group ensures every single material inside our...and stakeholdersBUSINESS EXPERTISE: Basic awareness of management tools and systems to evaluate reportsAble to work with constituent groups… more
- Tris Pharma (Monmouth Junction, NJ)
- …Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing ... and Drug Administration (FDA) standards and batch record specifications.The incumbent uses systems thinking and a holistic systems -based approach to drive… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Director, SD&PM Third Party Risk Systems & Governance Supplier Development & Performance Management (SD&PM) ... Company's products and services to our patients.--Primary Roles:-As a Third-Party Risk systems & processes owner, partners with SD&PM Risk Operations, Risk Domain… more
- Saint Francis Health System (Tulsa, OK)
- Saint Francis Health System is seeking a Registered Nurse (RN) Virtual Care for a nursing job in Tulsa, Oklahoma.Job Description & RequirementsSpecialty: Virtual ... via telemedicine technology, proactive surveillance of adverse physiological trends, assurance of appropriate prophylactic strategies, and medical chart review.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …4 or More Years First-hand knowledge of GAMP5, GxP and Non-GxP computer system validation and qualification and Computer Software Assurance (CSA), SDLC related ... around rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems… more
- Catalent (Philadelphia, PA)
- … System Validation documentation review and approval for instruments, equipment, and systems used in GXP Operations throughout the system life cycle. Other ... function is to build, monitor, and sustain a robust and effective quality system that delivers reliable, high-quality products that meet all customer and regulatory… more
- Catalent (St. Petersburg, FL)
- I. Department Overview: The Quality Assurance Department is responsible for providing leadership and support to the Catalent St. Petersburg site. The Department has ... the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, and Change Control.II. Basic Function: This position is… more
- Eisai, Inc (Nutley, NJ)
- …Information System Manager (CISM), Certified in Risk and Information Systems Control (CRISC), Certified Information Systems Auditor (CISA), or other ... regulatory compliance activities, maintain accurate documentation, and evaluate new system impacts. Organizational management involves strategic alignment, coaching, and… more
- Merck & Co. (Rahway, NJ)
- …in the Design Authority.- They will ensure the smooth operation of our SAP systems with a mindset towards continuous improvement.- Their expertise in SAP System ... with the overall business goals.Drive innovation and continuous improvement in SAP systems and processes.Team ManagementBuild and lead a high-performing team of SAP… more
- Merck & Co. (Rahway, NJ)
- …execution of capital and non-capital improvement projects, and the automation systems spanning various clinical manufacturing facilities. In this role, you will ... optimizing and maintaining our manufacturing processes using process control systems and automation and operational technologies.Responsibilities:Assist in the design,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold the ethical conduct of ... as applicable. Support MA/PV health authority inspections with adequate systems and process support, including facilitation of respective regulatory inspection… more
- Merck & Co. (North Wales, PA)
- …through the entire product lifecycle.Key areas of focus include:the assurance of deliverable quality and process compliance,effective deliverable development ... Engineering or related field with a minimum of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment. MS (preferred) in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical discipline is required A minimum of six (6) years of experience in Quality Assurance / Quality Systems or Compliance with a minimum of 4 of those within ... planning and execution of internal audits for all quality system areas for the manufacturing site; write audit reports,...users for audit process, and control access to any systems used to support audits/inspections. Provide support to quality… more
- Catalent (St. Petersburg, FL)
- Manager, QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management ... Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, Change Control, Client interface, Lab… more
- Catalent (St. Petersburg, FL)
- …QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The Department ... has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, and Change Control.The QA Product Manager provides customer… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Deliver the development and implementation of Research & Development (R&D) informatics systems and programs to support the business functions of Daiichi Sankyo (DS) ... Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, Informatics Services Project… more
- Catalent (Manassas, VA)
- POSITION SUMMARYThe Quality Assurance Specialist I is responsible for inspection and verification of the products and production processes along all the production ... our cGMP and execute corrective actions when needed. Assist the Quality Assurance team with special projects as required.Schedule: 6:00pm-6:00am night shift (2-2-3)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Create Purchase request from executed contract; and Update CLM system /trackers throughout the process.- Conduct simple negotiations review contractual amendments ... payment delays raised by Purchasing and Accounts Payable. Analyze system data, assess root cause factors, and determine actions...submit in Zycus for SAP creation.Additionally, Liaise with Quality Assurance group to obtain QA risk rating and audit… more
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