- Novo Nordisk Inc. (Plainsboro, NJ)
- … representatives and/or contingency workers. Essential Functions Leads and manages the NAO Quality PV Oversight support function for NNI Patient Safety (PS) with ... and procedures relevant to his/her area of work Provides support to other functional areas within NAO Quality PV Oversight and NAO Quality Department as… more
- Merck & Co. (Rahway, NJ)
- …by summarizing findings during documentation reviews. Collect, prepare and analyze data to support quality system metrics and planning. Support compliance ... activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality … more
- Insmed Incorporated (San Diego, CA)
- …(Essential Role Responsibilities):Establish and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections ... and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance (CQA)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the CAR-T manufacturing site.Oversee metrics, trending, and reporting of relevant quality systems records. Support CAPA site governance programDrive continuous ... Practices (cGMP).Manage multiple and complex cross-functional projects with many stakeholders. Support other quality systems activities, as needed. Support… more
- Repligen (San Diego, CA)
- …of proteins and antibodies in drug discovery and development, manufacturing, and quality assurance. The Laboratory Support Specialist will provide support ... worldwide. C Technologies, Inc. (CTI) is a Repligen company. The Laboratory Support Specialist is responsible for providing technical assistance and expertise to the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Vendor Assessment team to maintain a Center of Excellence (COE) for vendor quality assessment management Provides SME support to employees working within the ... health authority and/or stakeholder requirements Participates and or provides support to NAO Quality processes including but not limited to internal audits and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a manner consistent with global affiliate health authority and/or stakeholder requirements Provides support to NAO Quality processes including but not limited to ... FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved....find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …teams Support facility certification for new Manufacturing (process equipment & facility- support equipment) and Quality Control facilities as needed as well ... the Manufacturing Engineering department on cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups) Performs all job duties and… more
- Merck & Co. (Rahway, NJ)
- …action (CAPA).- Facilitate equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities.- Interface with ... (FM/GWES) and Original Equipment Manufacturers (OEM) and vendors.Provide engineering and quality engineering (QE) support , ensuring facility, utilities and… more
- Aequor (Thousand Oaks, CA)
- …within Quality Control at the Thousand Oaks site and to directly support both manufacturing and Quality Control operations. Under minimal supervision analyze ... Exposure to GMP and Aseptic technic and benchwork experience. Lab work. Support Microbiology lab with analytical testing. Pipetting water testing, Observing for… more
- Merck & Co. (Rahway, NJ)
- …regulatory standards (eg, FDA, cGMP), maintain optimal environmental conditions for product quality , and support continuous operations. The ideal candidate will ... programs, system efficiency/cost performance, energy optimization and provide technical support to partners, facility owners and engineering project/capital teams.Manage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Protocols) with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build the Site Readiness of ... responsible for EBR development and administration at the Raritan site to support production processing while liaising with other functions including but not limited… more
- Merck & Co. (Durham, NC)
- …an empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a day shift position, ... Technician is responsible for providing equipment troubleshooting and maintenance support to VMF Operations areas (sterile supply, weigh/dispense, media,… more
- Merck & Co. (Durham, NC)
- …an empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups.This is a night shift ... Technician is responsible for providing equipment troubleshooting and maintenance support to VMF Operations areas (sterile supply, weigh/dispense, media,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in line with company-wide policy and relevant regulatory requirementsCoordinate with broader DS quality teams to support GRA meeting company policies for ... role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes,… more
- Repligen (Waltham, MA)
- OverviewWe are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will a key role in ensuring the quality , compliance, and ... collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a key role in driving supplier… more
- Genmab (NJ)
- …of our Global Medical Writing team, you will drive the development of high- quality clinical documents to support operational, medical, and regulatory activities ... and lead review cycles.Provide expert peer review and editing support to elevate the quality of documents across the team.Help shape internal processes, tools,… more
- Repligen (Waltham, MA)
- …audit schedules; serve as host for site auditsMaintain risk-based strategy for overall Quality compliance across the organization and in support of the ISO ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology… more
- Aequor (Thousand Oaks, CA)
- …experience is more important. Candidates should be familiar with manufacturing or quality operations and understand the pace and expectations of a high-volume, ... without industry experience will not be considered. This position supports 's Quality Assurance program under the Plant QA organization providing daily oversight of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …deliver and continually improve data representation and delivery applications (including data quality ) in support of US Talent Acquisition Evaluates processes ... within Talent Acquisition and consults to provide recommendations in accordance with federal, state and local requirements Monitors survey data and identifies opportunities for improvement for the US Demonstrates advanced knowledge of the laws and policies… more
