- Merck & Co. (Rahway, NJ)
- …products.Technical Expertise:Utilize extensive experience in design controls, device transfer, control strategies device risk management, and design verification ... syringes, and complex drug delivery systems.Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process… more
- Merck & Co. (Rahway, NJ)
- …design and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and ... experts within the broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly automation, etc.), as well… more
- Merck & Co. (Rahway, NJ)
- …reports (SORs) to promote fast and efficient closure.As needed, safely perform High Risk Work involving hazardous energy control .Identify and follow through on ... opportunities to improve building flexibility, efficiency, compliance, and safety.Author lessons learnt and summary reports to capture knowledge gained.Mentor and help train rotational and new employees.This position's primary focus is executing batch… more
- Merck & Co. (Rahway, NJ)
- …be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and commercial combination ... apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program presentations for… more
- Merck & Co. (Rahway, NJ)
- …products and non-our company marketed products . - Analyzes and anticipates project risk s as they relate to clinical supply chain deliverables and prepares , ... needed - Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio… more
- Merck & Co. (Rahway, NJ)
- …projects, etc.)-Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence ... -Knowledge of order management, supply chain operations and document control . -#MSJR #eligibleforERP GCSCareer25 #VETJOBS #GCSCareer Current Employees apply HERE… more
- Aequor (East Syracuse, NY)
- …coordinating timely transfer of test methods with and to Quality Control laboratories is desired. Specific Knowledge, Skills, Abilities, etc.Strong written, verbal, ... deliverables within given timelines.Ability to problem solve and apply risk -based critical thinking in a technical environment.Demonstrated history of continuous… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply ... provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer,… more
- Novo Nordisk Inc. (Durham, NC)
- …machine learning for anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using predictive ... relevant areas Own self development & initiative to understand the site process control systems, data management systems, and differing data sources (PCS, MES, SAP,… more
- Merck & Co. (Rahway, NJ)
- …(MCAAS) primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityThe ... of the audits and assessments.Demonstrates knowledge of and techniques to assess risk and evaluate the effectiveness of internal controls in moderately complex… more
- Merck & Co. (Rahway, NJ)
- …expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a pivotal ... candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This… more
- Merck & Co. (Rahway, NJ)
- …needed. D emonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio ... Analysis, Detail-Oriented, Drug Development, Good Manufacturing Practices (GMP), Inventory Control System, Inventory Management, Management Process, Multiple Therapeutic Areas,… more
- Merck & Co. (Rahway, NJ)
- …The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering ... Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …certification for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued operation of ... with investigations Completes accurate and timely assessments associated with change control activities Ensures change control activities for systems are… more
- Merck & Co. (Rahway, NJ)
- …Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End Users. Conduct ... as User Guidance and Standard Operating Procedures (SOP) and change control management is desirable.Good understanding of SDLC Documentation requirements and… more
- Merck & Co. (Durham, NC)
- …degree of accuracyStrong analytical and problem-solving skills.- Strong risk -based decision-making skills.A positive, collaborative, consensus building approach to ... Communication, Customer-Focused, Data Analysis, Financial Forecasting, Inventory Accuracy, Inventory Control Management, Logistics Management, Logistics Planning, Management Process, Material… more
- BioAgilytix (San Diego, CA)
- …of laboratory systems and softwareAuthors and reviews validation deliverables ( risk assessment, requirements specification, IQ/OQ/PQ, etc.) Contributes to the ... and revision of Computer System Validation procedures and policies (validations, change control , data integrity), following 21 CFR Part 11, Annex 11, GxP, and… more
- Merck & Co. (Rahway, NJ)
- …development and chemistryHigh-throughput experimentation, automation, and process control .Knowledge of microbial fermentationCell culture predictive modeling (omics ... Line Engineering, Clinical Judgment, Communication, Flux Analysis, Human Health Risk Assessment, Innovative Thinking, Interpersonal Relationships, Mammalian Cell Culture,… more
- Aequor (Thousand Oaks, CA)
- …and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project ... Filling operations Experience with various quality systems including change control , deviations, corrective and preventative actions, and/or validation practices… more
- Merck & Co. (Rahway, NJ)
- …desired results. Reviews and defends stage-gate deliverables for programs including risk assessment and mitigation plans and engages in corporate governance meetings ... Skills:Business, Business, Compliance Investigations, Confidentiality, Cross-Cultural Awareness, Detail-Oriented, Document Control Systems, Electronic Common Technical Document (eCTD), Ethical Compliance,… more
