- Novo Nordisk Inc. (West Lebanon, IN)
- … while collaborating with the Engineering team to provide necessary documentation, quality system interaction, and performing a variety of highly diverse ... of BMS hardware and software Work with PM to support the commission the system , ensuring all devices and systems are correctly connected and functional Work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … standards are met.Proactively assess and address operational gaps related to quality systems and compliance, fostering a culture of sustainable ... validation of IT services and determining audit targets for GxP systems .ResponsibilitiesLeadership and Strategic DirectionThe Sr. Director, Data Quality and… more
- Genmab (NJ)
- …to internal teams and vendors.Support cross-study harmonization of data quality practices. Process Excellence and Standards DevelopmentDrive the development ... data oversight and leadership roles.Experience with external vendor management a plus.Proven expertise in protocol design, data quality management, and protocol… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or updated procedural documentation. In addition, this role will work closely with process owners, subject matter experts (SMEs) and Quality colleagues within ... Vault RIM)Work with GRA stakeholders to define appropriate KPIs/metrics to track process compliance, performance and adherenceWork with the data/ systems SMEs to… more
- Aequor (Thousand Oaks, CA)
- …change requests approved by management. 4. Work within the Information Services and Quality Systems teams to foster good communication throughout the project ... supervision, this position will perform routine procedures (ie, NC/CAPA/CC) and process improvements projects to support Corporate Quality Control. Specific… more
- Novo Nordisk Inc. (Durham, NC)
- …Seeking an experienced to Sr level Process Engineer to support the bulk process tableting line. This role will improve/develop systems & equipment for the ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...improvements. Develop plans to improve the performance of a process or set of systems , using green… more
- Merck & Co. (Durham, NC)
- …distribution, HVAC/R, and utility generation equipment.Electrical & Automation system process improvement, design, and optimization experienceTechnical ... detailed understanding of design, construction, control and maintenance of building systems and process equipment. Provides technical support and training… more
- Raytheon (Aurora, CO)
- …bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today's mission and stay ahead of tomorrow's threat. ... skills, are shaping the future of software development to efficiently deliver high- quality , secure software, by providing automated services that enable SW engineers… more
- Raytheon (Aurora, CO)
- …bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today's mission and stay ahead of tomorrow's threat. ... skills, are shaping the future of software development to efficiently deliver high- quality , secure software, by providing automated services that enable SW engineers… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... from bench top scale through commercial manufacturing scale. This individual provides expertise in support of manufacturing capacity expansions projects at our cGMP… more
- Cepheid (Miami, FL)
- …everything possible.The Sr. Quality Specialist is responsible for supporting quality systems activities related to assay development, specially design ... and Minitab.It would be a plus if you also possess previous experience in: Quality Systems / Quality Engineering background in molecular biology products or… more
- Beckman Coulter Diagnostics (Miami, FL)
- …in supplier monitoring and improvement activities such as supplier performance reviews, process or quality system audits, supplier change notifications, ... be a plus if you also possess previous experience in:Internal or External quality system auditingFDA regulated environmentKnowledge of GDT and ability to… more
- Beckman Coulter Diagnostics (Miami, FL)
- … quality engineering or supplier development within international manufacturing environments.Deep expertise in quality systems and tools, including risk ... certifications such as CQE, CQA, Six Sigma, or equivalent credentials in quality or process improvement.Working knowledge of regulatory standards, including ISO… more
- Twist BioScience (South San Francisco, CA)
- …closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams ... 21 CFR Part 11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system... (SCADA, DCS, PLC, HMI) from a software integration perspective. Expertise in computer system validation (CSV) and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and instructional systems design preferred Knowledge of pharmaceutical manufacturing quality system , including knowledge of FDA requirements preferred Strong ... relational databases required Knowledgeable in GMP processes, Quality Management System (QMS), & standard improvement systems preferred Demonstrated … more
- Merck & Co. (North Wales, PA)
- …and expereince:Must have experience in CDISC and ADaM standards and in ensuring process compliance and deliverable quality .Significant expertise in SAS and ... clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; and systems and database expertise also required.Applicant must also possess… more
- AUROBINDO (Durham, NC)
- …very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance, Quality control, and ... validation deliverables associated with various Aurolifesystems such as LIMS, Quality Assurance Management System (QAMS),Waters Empower, Document Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its ... in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …refrigeration, pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and ... EPA, OSHA and DEA)HVAC operation, building automation and environmental monitoring systems , process maintenance, instrumentation, automation PLCs, VFDs and… more
- Merck & Co. (Rahway, NJ)
- …testing, and process validation, with a strong understanding of quality management systems and regulatory compliance. Exceptional project management skills ... and maintain proficiency in ISO 13485, ISO 14971, and other relevant quality management systems . Qualifications: EducationRequired - Technical BS degree or… more
