- Twist BioScience (South San Francisco, CA)
- …or equivalent accounting certification preferredDeep understanding of SOX regulations and internal control frameworks, including the Sarbanes-Oxley Act, the 2013 ... owners to perform management assessment of risk over internal controls and identify opportunities for control ...SOX compliance activities and enhance efficiency Partner with IT control owners on implementation of new systems … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … control activities Partners with the financial compliance group to ensure an efficient internal control set-up exists and is adhered Engages internal and ... team based in Bangalore, India. Other key r0elationships include internal and external auditors, and government agencies. Essential Functions...as needed Own and manage testing of local owned systems - SAP and Web Benefit audits Coordinates annual… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …participating in high level organizational decision making. The Police Chief has internal control over police activities and personnel and exercises discretion ... or indirectly. Develops, implements, monitors, and adjusts effective communication systems throughout the police department. Plans, coordinate, manages and evaluates… more
- Merck & Co. (North Wales, PA)
- …of digital transformation in the biopharmaceutical industry. As a Product Owner - Change Control , you will play a pivotal role in simplifying our Quality Management ... System (QMS) technology stack and enhancing user experience. This...IT solutions which deliver maximum business value.Ensure that Change Control Digital Solutions are true enablers to standard processes… more
- Tris Pharma (Monmouth Junction, NJ)
- …Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports, oversees ... and Drug Administration (FDA) standards and batch record specifications.The incumbent uses systems thinking and a holistic systems -based approach to drive… more
- Merck & Co. (Durham, NC)
- … equipment, including Programmable Logic Controllers (PLCs) and Distributed Control Systems (DCS).Prepares technical documentation (preventative maintenance ... .- Must be able to read electrical prints, P&ID's and understand P&ID control loops. Extensive industrial experience involving utility systems with a strong… 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 ... will be responsible for problem resolution, administration and monitoring of process control systems , data collection & analytics, and troubleshooting. They will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …improvement of the internal audit process.Support the planning and execution of internal audits for all quality system areas for the manufacturing site; ... team meetings, mentor site users for audit process, and control access to any systems used to...six (6) years of experience in Quality Assurance/ Quality Systems or ComplianceExperience conducting internal audits (self-inspection),… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Merck & Co. (Durham, NC)
- …using inventory management and maintenance planning software (MRP/ERP) such as SAP, automated control systems and electronic batch record systems . Experience ... strong collaboration and communication skills to enable interfacing with both internal contacts (site level) and external contacts (external customers, sister sites,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and process improvement projects.Identify, and oversee changes within quality systems .Assure equipment maintenance and calibration, and internal audits ... precautions and hazardous and biohazardous chemical handling.Knowledge of change control practices for major equipment, important systems , instrumentation,… more
- Merck & Co. (Baton Rouge, LA)
- …Animal Health Intelligence North American Facilities. Responsibilities include system upgrades, troubleshooting issues, identifying trends, process monitoring, ... with senior leadership. SPECIFIC RESPONSIBILITIES: Evaluates automated and information technology systems and develops strategies to optimize and ensure quality and… more
- Merck & Co. (Rahway, NJ)
- …IT Compliance Processes and IT's enabling processes and services including System Development Life Cycle (SDLC), Corrective and Preventative Actions (CAPA), ... Personnel Qualification, IT Regulatory Control Services, Independent Compliance Monitoring including any supporting records and information.Key… more
- Merck & Co. (Rahway, NJ)
- …. This individual serves as the primary GCS point of contact to stakeholders both internal and external to GCS and serve s as the GCS spokesperson at clinical ... partners and senior leaders. Works directly in the SAP system to establish a consolidated , visible forecast for...relationship management. - Technical Proficiency: familiarity with supply chain systems and software ( eg SAP or Oracle) and… more
- Merck & Co. (South San Francisco, CA)
- …include but are not limited to:Oversight and management of electrical, mechanical, plumbing systems such as HVAC systems , lighting, fire safety systems , ... gas, among others.Oversight and management of Gas, plumbing, and heating, HVAC systems , lighting, electrical, and mechanical, fire safety systems , building… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …leader and decision maker for the Quality Department and Quality Management System . This position is ultimately responsible for the product quality received by ... the customer and the quality system integrity expected by the customer. The Quality Director...monitoring and oversee the conformance to the QMS through internal audits and management review. In addition, the Quality… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Design Control and Risk Management Data Manager, you are a key member of the Device Development Team. Your will main responsibility is to develop ... cycle of a product.Key Responsibilities Include the following:Partner with the Design Control and Risk Management leads to determine the data relationships and… more
- Aequor (Framingham, MA)
- …of computerized systems in biopharmaceutical manufacturing environment, ie, Distributed Control System , Process Data Historian, LIMS, and MES. Experience ... cost analysis. Lead the creation and use of digital process data analytic systems . Partner with internal and external functions to identify, prioritize, scale… more
- Merck & Co. (Durham, NC)
- …help drive our Strategic Operating Priorities.Invent - Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical NeedsExecute - ... the Sterility Assurance team providing knowledge for risk mitigation and contamination control . -The candidate will gain a robust understanding of the aseptic… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …in process validations, and continues with overseeing risk using statistical quality control during manufacturing. In addition, addressing known issues with a strong ... Corrective and Preventive Action system to ensure the root cause is identified and...within the company. The Quality Engineer will participate in Internal Audits as directed by the Quality Manager. In… more
