- Twist BioScience (South San Francisco, CA)
- …process owners, IT, and accounting to help achieve ongoing design, review control documentation, and remediation of controls for Sarbanes-Oxley complianceLead ... with control owners to perform management assessment of risk over internal controls and identify opportunities for control improvement and design of new… more
- Merck & Co. (Durham, NC)
- …product, and laboratory testing for the BCG vaccine.The Senior Specialist, Quality Control participates in a team of analysts in the development, validation, and ... equipment validation, and GMP laboratory readiness.- The Senior Specialist, Quality Control will be responsible for starting testing in new laboratories using… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. SummaryThe Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for developing/proposing integrated CMC ... designed strategy, as well as developing activity plan, and budget for project . He/she (or subordinates) will lead cross-functional product decision and manage … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Quality Control Testing Scheduler as part of the Quality team based in Raritan, NJ. ... QC Testing Scheduler to join our team for Quality Control . The ideal candidate will manage and maintain our...and desired outcomes to make effective decisions.o Employs good project management principles to appropriately align time, resources, and… more
- Twist BioScience (South San Francisco, CA)
- To add to our growth, we are seeking an Internal Audit Project Sr Manager with Tech industry and public accounting experience. The role will report to the Sr. ... to the finance/ accounting and cross-functional members to ensure control performance and the sustainability of the process as...candidate will have a proven track record of audit project management and SOX 404 compliance. You are strong… more
- Merck & Co. (Rahway, NJ)
- …development; manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence ... execution against the established requirements.Represent Device Development and the project -specific Device Working Groups on cross-functional teams, including the… more
- AUROBINDO (Durham, NC)
- …team with expertise in manufacturing, R&D, Quality Assurance and Quality control , and regulatory affairs. In addition to several formulations under manufacture, ... transfer, with strong knowledge of manufacturing, analytical, and quality control processes. Skilled in trace-level quantification of impurities using various… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …system and related technologies.ResponsibilitiesManages all payroll supporting processes and controls which include:Provides audit support for internal and external ... are met. Provides information to other internal departments where deemed appropriate.Develop project plans and manages the Year-End payroll project activities… more
- Merck & Co. (Durham, NC)
- …duties will include support of site business processes, such as change control , deviation management, audits and regulatory inspections.- The Manager will be ... identify, evaluate and implement process improvements that expand site capabilitiesApply project management concepts and techniques as they relate to analytical… more
- Merck & Co. (Rahway, NJ)
- …and designing custom forms, emails and automated reportingDesigning and implementing controls to ensure accuracy and integrity of dataIdentifying problem areas, and ... assisting with troubleshooting issues/problems; assisting in implementing new controls as neededIdentifying training opportunities and train trademark staff on use… more
- Genmab (Plainsboro, NJ)
- …Drug Supply Manager, of the following tasks:Global Clinical Drug Supply Project /Trial ManagementObtain Project /Trial specific information to initiate drug supply ... new/additional scenarios) that may impact clinical drug supply)Create and maintain program/ project and trial IMP/AMP forecast and demand plans throughout the trial… more
- Merck & Co. (Durham, NC)
- …ensure successful execution of method transfer or method validation activities.Apply project management concepts and techniques as they relate to laboratory testing ... start-up, regulatory requirements for method transfer/validation project timelines and budgetingBuild knowledge of the company, processes and internal/external… more
- Merck & Co. (Rahway, NJ)
- …role, the successful candidate will be responsible to: Coordinate project planning, resourcing, progress reporting, troubleshooting and people management.Serve as ... multifaceted projects as the leader of a cross-functional team.-Ensures project results meet requirements regarding technical quality, reliability, schedule, and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Utilities), you will provide cross-functional support to operations, maintenance, quality and project teams for site GMP utilities. You will be setting priorities, ... utilities and HVAC systems.Participate in clean utilities validation activities during project life cycle.You will lead or support overall compliance requirements… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …aseptically filled pharmaceutical products.Job Responsibilities:Draft engineering change controlsPresent change controls to the Change Control Review Board ... events, ensuring accurate and timely reportingDevelop and deliver presentations on project updates, change controls , and related topicsPerform other duties… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …scheduling and financial requirements. Communicate status of projects to applicable project team Project Installation Support: Sub-contractor supervision, BMS ... system start-up, commissioning, and training Project Startup: Validate network functionality, provide programming support, and certify the operation of the BMS… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …individual will be responsible in handling day-to-day activities inclusive of project execution and management, vendor management, data life cycle management, ... company standards, policies and procedures.Handling day-to-day activities inclusive of project execution and management, vendor management, data management, life… more
- Merck & Co. (Rahway, NJ)
- …modeling, end-to-end flowsheets and digital twins, model-based process controls , plant and process-economics (including facility fit, cadence, scheduling, ... and troubleshooting. Champion the use of computational techniques to influence project teams and the organization. Drive tangible outcomes: reduced costs, fewer… more
- Novo Nordisk Inc. (Durham, NC)
- …operation of identified local manufacturing applications. Improve reliability of process control systems to meet current & projected customer, business & regulatory ... plans Own self development & initiative to understand the site process control systems Support audits & inspections as SME for specified process applications… more
- Merck & Co. (Rahway, NJ)
- …terms to facilitate cross-functional understanding and to support project timelines.Development experience in risk-oriented, regulated environmentsDevelopment ... Skills:Experience with medical device development with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management… more
