- Merck & Co. (Durham, NC)
- …(MES), Manufacturing Process Validation, Process Optimization, Procurement, Regulatory Compliance, Risk Control Assessment, Root Cause Analysis (RCA), SAP ... edit technical documents to support regulatory filings including technical reports and risk assessments Author or approve Change Control documentation for… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal ... of the following: process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports,… more
- Merck & Co. (Durham, NC)
- …technical documents to support regulatory filings including technical protocols, reports and risk assessments - Author Change Control documentation for complex ... implement solutions. Off-shift and weekend coverage will be required based on business unit needs and specific assignments. - The role encompasses technical services… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply ... External Manufacturing Operations is accountable for establishing a strong business partnership and ensuring excellence in Compliance, Supply, Continuous… more
- Merck & Co. (Rahway, NJ)
- …and techniques to assess risk and evaluate the effectiveness of internal controls in moderately complex business scenarios in accordance with ... company's divisions and functions to evaluate the adequacy of internal controls and deliver audit reports that add value...timelines.Applies knowledge to analyze and evaluate business scenarios following a risk based approach… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leads and provides actionable recommendations based on a) thorough analysis of internal and external business issues and environmental factors b) careful ... Relationships Reports to the VP, Enterprise Insights. Has responsibility of cultivating internal and external relationships that bring value and insights to the… more
- Merck & Co. (Durham, NC)
- …and projects to optimal execution strategies that carefully consider complexity, geography, risk and business impact.Find the best partners for the execution ... Job DescriptionOur Engineers support internal and external manufacturing operations remain operational, continuously...a keen focus on clear and thorough terms, appropriate risk allocation and insurance coverage.Coach and assess teams' use… more
- Merck & Co. (Rahway, NJ)
- …(SORs) to promote fast and efficient closure. - As needed, safely perform High Risk Work involving hazardous energy control . - Identify and follow through on ... (SM PR&D) organization. The SSO pilot plant enables gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing… more
- Merck & Co. (North Wales, PA)
- …Compliance Investigations, Confidentiality, Cross-Cultural Awareness, Detail-Oriented, Document Control Systems, Electronic Common Technical Document (eCTD), Ethical ... desired results. Reviews and defends stage-gate deliverables for programs including risk assessment and mitigation plans and engages in corporate governance meetings… more
- Tris Pharma (Monmouth Junction, NJ)
- …and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally importance to each ... and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with supervision and conduct testing Core roles include communication, compliance, risk management, and use of current technology System Design and Specification ... Contribute to design and specify BMS systems to control HVAC and other Critical Systems Contribute to select...engineering data Participate in on-call rotations, including weekends and non- business hours, to provide support for critical BMS, EMS… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …assesses updates and impact.Key Relationships: establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels ... 7 years of relevant experience is required. Demonstrated experience translating business needs to system requirements. Cell/Gene Therapy cGMP manufacturing and… more
- Cepheid (Miami, FL)
- …for supporting quality systems activities related to assay development, specially design control and risk management activities in accordance with FDA and ... other global regulations ISO 13485 and ISO 14971.Experience in implementing design control and risk management activities.Experience with technical data and… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …talents together to advance human health for tomorrow.Learn about the Danaher Business System which makes everything possible.The Staff Quality Assurance Engineer or ... is responsible for facilitating application of quality system and design control processes with teams across Beckman Coulter Life Science products including… more
- Mizuho Corporate Bank (New York, NY)
- Business Risk and Control - Internal Control Testing (ICT) AVP: Business Risk and Control (BRC) is a 1st line of defense Operational ... and legal entities across Mizuho US Operations (MUSO). The Business Risk and Control team...based Internal Controls Testing (ICT) Program. As Business Risk and Control ICT… more
- Grant Thornton (Philadelphia, PA)
- …Review operational, financial, and technology processes to provide clients with an assessment of business risk , internal control , and the overall ... business needs by helping them understand their business risks, and assist in addressing risk ...the development and execution of Sarbanes-Oxley (SOX) compliance and internal control over financial reporting programs for… more
- Grant Thornton (Pittsburgh, PA)
- …Your day-to-day may include: + Review operational, financial, and technology processes to assess business risk , internal control , and the overall ... business needs by helping them understand their business risks, and assist in addressing risk ...performing financial, operational, and system audits, as well as business process control reviews + Ability to… more
- Warner Bros. Discovery (Atlanta, GA)
- … strategies and objectives. This includes actively supporting the business with risk , process and internal control perspectives in ongoing transformation ... synergies. In this pivotal role, you will serve as a business process, risk , internal control , and Internal Audit (IA) subject matter expert across… more
- Grant Thornton (Dallas, TX)
- …across multiple risk domains to provide management with an individual assessment of business risk , internal control , and the overall effectiveness ... As the Controls Advisory Managing Director, you'll lead business process control reviews and special projects across multiple risk domains for your risk … more
- Deloitte (Morristown, NJ)
- …or FFIEC 101 + Understanding of business processes, regulatory requirements, risk management, internal control management, process, data and technology ... governance processes + Developing and implementing regulatory reporting policies, including risk and control assessments, operational and data controls, and… more
