- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Control Senior Specialist plays a critical role in ensuring the quality of our products by managing laboratory data and overseeing ... resources, when necessary, to support manufacturing processes. Responsibilities of the Quality Control Senior Specialist include leading routine testing of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Cell Therapy Manufacturing Plant. In addition, the candidate must have Quality Risk Assessment experience in the pharmaceutical industry.Primary responsibilities ... risk assessment plans. Key Responsibilities Follow QRM ( Quality Risk Management) process per ICH Q9,...risk , evaluate the risks and work resources to control the risks based on failure analysis results. Plan… more
- Merck & Co. (Rahway, NJ)
- …sterile processing and sterility assurance practices and guidelinesStrong experience with QRM ( Quality Risk Management)Strong working knowledge of SDLC, GAMP and ... filling, and lyophilization, and supporting clean utilities.Familiarity with change control systems and Quality assessment of change...then your employment may pose an undue burden to business operations, in which case you may not be… more
- Merck & Co. (Durham, NC)
- …support to assigned areas of focus including but not limited to quality risk management, strategy development, development/revision of standard operating ... priorities and complex problems in a fast-paced environment.Aseptic manufacturing and GMP quality experience.Experience with Quality Risk Management and… more
- Tris Pharma (Monmouth Junction, NJ)
- …(CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior ... Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.The Lab Senior… more
- Merck & Co. (Rahway, NJ)
- …and development; manufacturing process development, qualification, and validation; and, design control and risk management techniques to positively support and ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… more
- Merck & Co. (Rahway, NJ)
- …needs to CRA manager and/or functional vendor and internal management as needed. 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
- Merck & Co. (Durham, NC)
- …Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business )Adapt - Develop Our People, Culture and Business Model to ... maintaining accurate documentation of activitiesUndertaking SAP transactions and change control activities including spare part lists and preventative maintenance… more
- Merck & Co. (Rahway, NJ)
- …disciplineRequired Experience and Skills:A minimum of three years of IT audit or Risk experienceBasic understanding of security and control risks in emerging ... Corporate Audit and Assurance Services' (MCAAS) provides value-added independent and risk based audit, assurance and advisory services.Position Overview Function and… more
- EY (Hoboken, NJ)
- … through innovative, secure solutions that provide speed to market and business value. The opportunityThe Technology Assurance, Risk , and Policy (TARP) ... and enforced across all levels of the organization. The Control & Risk Assessment team sits within... Risk Management, Internal Audit, Area and Regional Risk & Data teams, Service Line Quality … more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required. Responsible for… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.Responsible for… more
- Catalent (St. Petersburg, FL)
- …with other functional areas (eg Product Development, Operations, Customer Service, Validation, Quality Control , etc.) to ensure continued compliance for the ... Manager may be dependent upon the needs of the business and structure of the Quality Unit...as QA in pharmaceutical industries. Prior experience working with quality control , manufacturing, product development preferred (Feasibility… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to ensure trial conduct is completed in compliance and meets Novo Nordisk's business standards Risk management: Assessing and mitigating risks associated with ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....execution and spend of ancillary supplies for NACD. Ensure business needs are met through alignment of business… more
- Merck & Co. (Durham, NC)
- …individual will partner with Maintenance management, and work with Manufacturing Operations, Quality , and Global Engineering Services as a member of the EMSS. The ... service. Demonstrates ability to meet customer expectations in term of quality /quantity and on-time delivery as appropriate.Oversee and maintain schedule adherence… more
- Tris Pharma (Monmouth Junction, NJ)
- … Quality Assurance (QA) Research and Development (R&D) Analytical Chemist supports Quality Control (QC) and Analytical R&D (AR&D) activities by initiating ... softwareExperience with wet chemistry and chemistry related to sampling methods, quality control systems, analysis and documentation practices and… more
- Merck & Co. (Rahway, NJ)
- …Organics Pilot Plant (SSO): - The SSO uses an Emerson DeltaV Distributed Control System.- The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in ... prepare Standard Operating Procedures (SOP) and cGMP documents.Experience with Quality SystemsExperience in supporting compliance investigations and change management.Familiarity… more
- Tris Pharma (Monmouth Junction, NJ)
- …takes a leadership role for other chemists on the QA R&D team in supporting Quality Control (QC) and Analytical R&D (AR&D) activities. These include but are not ... softwareExperience with wet chemistry and chemistry related to sampling methods, quality control systems, analysis and documentation practices and… more
- Merck & Co. (Rahway, NJ)
- …of services, ensuring that agreed service levels, security requirements and other quality standards are met.Change Control Experience - ability to develop, ... with Manufacturing Division, Animal Health Division and Research & Development Division, business areas to gain understanding of requirements and to establish and… more
