- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple and complex cross-functional projects with many stakeholders.Support other quality systems activities, as needed.Support drafting, review and approval ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role… more
- Merck & Co. (North Wales, PA)
- …to meet the value evidence needs of payers, advisory committees health systems , and clinicians.The incumbent can generate these plans based on direct interactions ... purposes.Develops and evaluates health programs leveraging different parts of health care systems that can enhance value and use of products.Implements programs to… more
- Merck & Co. (Rahway, NJ)
- …and consultation services for regulatory reporting (eg, BPDR, DPR)Author and/or review global standards and procedures related to biologics, vaccines, and finished ... a health authority as an inspector, investigator, compliance officer, reviewer , or assessorExperience creating or assessing remediation plans#EBRGCurrent Employees… more
- Paul Davis Restoration, Inc. (Jacksonville, FL)
- …of the department and network during a catastrophe event. Position: Full-Service Reviewer Reports to: Review Team Manager Location: Hybrid Essential ... Join Our National Team as a Full-Service Reviewer ! Are you looking to leverage your expertise...on skill and expertise, to allow full flexibility to review multiple/all of the job types referenced; serving as… more
- Merck & Co. (Durham, NC)
- …with established safety, GMP, and calibration/maintenance procedures.Uses the SAP work order system to review work requests, identify required stock and ... and when required calibration activities to ensure applicable equipment and systems are maintained in a compliant state.Maintains the integrity of equipment… more
- Merck & Co. (Rahway, NJ)
- …are maintained and are suitable for both GMP and developmental use.- Author, review and approve GMP procedures and documentation, with an emphasis on Qualification ... and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute… more
- Novo Nordisk Inc. (Charlotte, NC)
- …Nordisk within a specified geographic area, engaging with selected health systems , key academic centers, specialists, primary care providers, and other stakeholders. ... Novo Nordisk as a frontrunner in the cardiometabolic care market. The Health System Portfolio Specialist I is responsible for achieving sales targets by effectively… more
- Twist BioScience (South San Francisco, CA)
- …RoleWe are seeking an experienced Staff Engineer specializing in Salesforce (SFDC) and systems integrations to join our technology team locally at the South San ... product lines and deep understanding of integration to eCommerce and ERP systems to ensure scalable, robust, and flexible cross-functional solutions that support our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide expertise and ... providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy… more
- Merck & Co. (Rahway, NJ)
- …chain deliverables and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Works directly in the SAP ... system to establish a consolidated , visible forecast for...relationship management. - Technical Proficiency: familiarity with supply chain systems and software ( eg SAP or Oracle) and… more
- Merck & Co. (Rahway, NJ)
- …packages to ensure 21 CFR part 11 ComplianceSupport standardization activities for System Development Life CyclePrepare, review , and approve documentation such ... in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or upgraded instrumentation or software… more
- Actalent (St. Louis, MO)
- …Scan and archive completed records into the electronic database and physical storage system . Input data into warehouse management systems (eg, Dynamics 365) and ... Associate Job Description The QA Associate is responsible for the rigorous review , verification, and archival of batch records and associated documentation to ensure… more
- Eisai, Inc (Nutley, NJ)
- …and CDISC standards. The role will require excellent technical skills in SAS systems and application development and experience. The Associate Director must be a ... and oversees JReview and SAS program development for clinical data processing, data review reports and listings. This includes but is not limited to: Program design… more
- Merck & Co. (Rahway, NJ)
- …chain deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders. -Responsible and accountable ... assigned studies such as IRT & Microsoft PowerApps. -Works directly in the SAP system to ensure a robust and consolidated forecast for CFGs is maintained. --Report… more
- Merck & Co. (Durham, NC)
- …between Maintenance, Deviation Management, Quality and other Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage ... to support investigations and develop appropriate CAPAs which lead to program improvements. Review and approve out of tolerance (OOT) records and ensure quality… more
- Eisai, Inc (Raleigh, NC)
- …collaboration across teams.ResponsibilitiesExecute core processes within Quality area: Review manufacturing batch records for completeness, accuracy, and compliance ... with entering events, change controls, and complaints into quality management system .Conduct ongoing tracking, documentation, and reporting of quality goals and… more
- Lee County, FL (Fort Myers, FL)
- …water infrastructure, engineering, transportation, zoning, comprehensive plan, and utility systems for compliance with requirements. Review and interprets ... the Lee County Land Development Code and coordinating the review and analysis of applications for development orders, limited...County employees eligible to participate in the Florida Retirement System (FRS) are required to contribute 3% of each… more
- Merck & Co. (Durham, NC)
- …between Maintenance, Deviation Management, Quality and other Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage ... to support investigations and develop appropriate CAPAs which lead to program improvements. Review and approve out of tolerance (OOT) records and ensure quality… more
- Novo Nordisk Inc. (Boston, MA)
- …Nordisk within a specified geographic area, engaging with selected health systems , key academic centers, specialists, primary care providers, and other stakeholders. ... Management Assess and adapt sales and promotion strategies to align with health system account practices, care pathway decisions and managed care impact in the… more
- Merck & Co. (Durham, NC)
- …of the Site Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This Individual will ... and engineering groups.- Supports a spectrum of sophisticated automated systems within Manufacturing Operations; providing multiple opportunities to learn new… more
