- Merck & Co. (Rahway, NJ)
- …within Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk management ... DescriptionDevice Development Associate Principal Scientist - Development Strategy, Design Controls (Associate Director Equivalent) Our company's Device Development & Technology… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Principal Scientist, Process Control and Data Analytics will be responsible for leading a team focused on developing and implementing product ... control strategies, statistical analysis, and advanced statistical methods for...across processes end to end, analyzing tests methods and controls , to generate a comprehensive assessment of product performance.-… more
- Merck & Co. (Rahway, NJ)
- …for commercializing new products.Technical Expertise:Utilize extensive experience in design controls , device transfer, control strategies device risk management, ... prefilled syringes, and complex drug delivery systems.Proven expertise in design controls , risk analysis, control strategies, design verification testing, and… more
- Merck & Co. (Rahway, NJ)
- …and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence ... engineering design, engineering analysis and testing, medical device design controls , risk management, test method/ fixture development, design verification and… more
- Merck & Co. (Rahway, NJ)
- …equipment to enable development of product specific processes and controls with a focus on DFM/DFA principles.Understanding of autoinjector/parenteral/pre-filled ... to capture patient and process risk and identify appropriate in-process controls to ensure robust and efficient throughput.Develop characterization plans and… more
- Merck & Co. (Rahway, NJ)
- …mitigate risks, and continuously enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve ... seamless product supply with an end-to-end mindset.Initiate and drive change controls to completion.Provide rapid support to External Partners to resolve… more
- Merck & Co. (Durham, NC)
- …NC.This Individual will be-responsible for problem resolution, implementation of process control , data collection techniques, and troubleshooting in compliance ... Specialist, is a member of the Site Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham,… more
- Merck & Co. (Rahway, NJ)
- …role in driving member satisfaction, improving efficiencies, and ensuring regulatory compliance while advancing the credit union's payments strategy in alignment ... for performance, member experience, and operational efficiency.Risk & ComplianceMaintain strong controls and procedures to comply with all applicable laws and… more
- Merck & Co. (Rahway, NJ)
- …Driving License:Hazardous Material(s):Required Skills:Business, Business, Compliance Investigations, Confidentiality, Cross-Cultural Awareness, Detail-Oriented, ... Control Systems, Electronic Common Technical Document (eCTD), Ethical Compliance , Global Health, Global Program Development, High Performance Team Building,… more
- Merck & Co. (Rahway, NJ)
- …education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance , Management Process, Manufacturing Quality Control , Medical Supply ... management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and process needs… more
- Merck & Co. (Rahway, NJ)
- …investigations with a strong focus on quality and regulatory compliance .Excel in impurity isolation, unknown peak identification, characterization of degradation ... chainIntroduce and lead strategic initiatives related to technical advancement, compliance , and business improvements.Demonstrate the ability to influence meaningful… more
- Merck & Co. (Rahway, NJ)
- …knowledge of application security and Cloud security including:Application security controls as part of the software development life cycleCloud ... to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate… more
- Merck & Co. (Millsboro, DE)
- …corporate and regulatory policies.Review production records for completeness and compliance to departmental and/or Site Standard Operating Procedures (SOPs).Provide ... to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate… more
- Merck & Co. (Durham, NC)
- …drug product, including product inspection, warehouse, utilities, and quality control laboratories.The Specialist, Operations will be responsible for providing ... work and projects, understand full process requirements such as safety, compliance , processProviding guidance for daily production support, projects, deviations and… more
- Merck & Co. (Rahway, NJ)
- …substance processes. Your insights will be crucial for establishing an integrated control strategy suitable for commercialization and licensure for the products in ... design of experiments (DOE) and data analysis, as well as statistical process control (SPC) and multivariate analysis (MVA).Why Join Us?At-Our Company, you will be… 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. ... as User Guidance and Standard Operating Procedures (SOP) and change control management is desirable.Good understanding of SDLC Documentation requirements and… more
- Merck & Co. (Rahway, NJ)
- …industry.Required Experience and Skills: Strong background in integrated analytical control strategy development and execution. Demonstrated ability to lead a ... knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related impurities in… more
- Merck & Co. (Rahway, NJ)
- …will provide hands on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices ... closure.As needed, safely perform High Risk Work involving hazardous energy control .Identify and follow through on opportunities to improve building flexibility,… more
- Merck & Co. (Rahway, NJ)
- …Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and ... expected, as well as advancing a culture of scientific excellence, compliance mindset and collaboration with various partners and stakeholders in… more
