- Exela Pharma Sciences, LLC (Lenoir, NC)
- …manage the departments of Quality Assurance, Sterility Assurance, and Quality Control .Experience Requirements 15+ years of relevant and current work ... Position SummaryThe Vice President, Quality Assurance will serve as an in-house subject matter expert on GxP compliance. He/she will also serve as key… more
- Merck & Co. (North Wales, PA)
- …and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools.Knowledge and ... It is business critical that our company receives consistent, accurate, high- quality data from clinical trials conducted worldwide. REAIM ( Risk Evaluation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR). ... team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators and… more
- Merck & Co. (Durham, NC)
- …is a member of the Automation team responsible for the support of process control systems used in manufacturing operations located in Durham, NC.- We use a variety ... of industrial control platforms to manufacture vaccines, including DeltaV, PLCs, MES,...an empowered team culture including significant interaction with manufacturing, quality and engineering groups.- This position is for nighttime… more
- Aequor (New Brunswick, NJ)
- …required premarket stability program in support of the change Perform change control impact assessments and document the stability assessment in change controls. ... Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards. Leads work activities involving Change… more
- Merck & Co. (Rahway, NJ)
- … control loops.Working knowledge of general OPC interfacesSubject Matter Expert on Control SystemsUnderstanding of Object-Oriented languagesStrong background ... Organics Pilot Plant (SSO): - The SSO uses an Emerson DeltaV Distributed Control System.- The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in… more
- Aequor (Seattle, WA)
- …(LMS) Administrator will manage and coordinate training events and record and control training information for the Learning Management System (LMS). The position ... will report to the Global Cell Therapy Quality Training Lead REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: Must have basic GMP and Quality knowledge.… more
- Merck & Co. (Rahway, NJ)
- …needs to CRA-Manager and/or functional vendor and internal management as needed.o Performs Quality control visits as required.Leads local study teams to high ... with-ICH/GCP and country regulations, Our Company policies and procedures, quality standards and-adverse event reporting requirements internally and externally.The… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …roles and responsibilities Work closely with Engineering, Automation, Validation, IT, Manufacturing, Quality Assurance and Quality Control , on project teams ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a... in cGMP documentation practice & understanding of change control processes Expert understanding of validation/system development… more
- Catalent (St. Petersburg, FL)
- …Manager provides customer service, with the highest integrity, focused on quality and compliance with partnership with Catalent St. Petersburg's customers and ... St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited… more
- Merck & Co. (Rahway, NJ)
- …seamless access to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data accuracy, completeness, and ... disease-specific databases (eg, Cancer Genome Atlas).Stay informed about the availability, quality , and limitations of various data sources and their relevance to… more
- Tris Pharma (Monmouth Junction, NJ)
- …Senior Director, Clinical Operations.The Senior Director, Clinical Operations provides expert strategic, scientific and operational leadership by leading strategic ... of clinical study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations and/or guidance. Collaborating closely… more
- Merck & Co. (Rahway, NJ)
- …to establish effective communication between systems and devices.Apply expertise in control systems and control strategies to optimize process ... or IT systems.Participate in audits and training programs as the subject matter expert (SME) for area of responsibility. Data: Utilize data science and data… more
- Catalent (St. Petersburg, FL)
- …to Quality Systems, Finished Product Batch Release, and Change Control .The QA Product Manager provides customer service, with the highest integrity, focused ... Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …such as Omnichannel Marketing, brand management, Patient Support, IT Operations, IT Quality , and Novo Nordisk Global Business Services as well as external partners ... websites/web applications and achieve required KPIs Serve as a subject matter expert and lead architecture design of websites and web applications Conduct necessary… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development and content publishing processes in an SOP and ensure compliance Manage quality control of all NNI healthcare professional websites assuring no dead ... partners prior to implementation. Acts as the subject matter expert and strategist for designated customer segment, ensuring therapeutic...links, browser compatibility and other standard quality control processes Manage Web Trends tracking… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Ensures quality control activities are aligned with industry, regulatory and ... 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global, regional and local products. They also support labeling activities and provide expert guidance for labels in all markets where Daiichi Sankyo operates. This ... develop, oversee, and manage implementation of global labeling development and quality review processes, templates, metrics, and systems, while ensuring compliance… more
- Advocate Aurora Health (Sheboygan, WI)
- …using principles of aseptic technique and standard precautions / infection control guidelines. Assists the physician/provider with procedures and surgeries such as ... implementation of staff orientation, competency and educational activities. Acts as an expert clinical and department resource. May provide work direction to other… more
- ThermoFisher Scientific (Middletown, VA)
- **Job Description** Thermo Fisher Scientific is seeking an expert Quality Control Laboratory Technician I to join our Clinical Diagnostics Division (CDD). ... This position offers a key role in our Clinical Diagnostics Reagents (CDR) Quality Control Laboratory and provides excellent opportunities for career development… more
