- Repligen (Waltham, MA)
- … control framework that spans all global operations.Lead the SOX compliance program, including risk assessments, documentation , testing, remediation, ... and execute compliance strategy across a global company Lead SOX risk assessments, audits, and remediation efforts Partner with senior leaders to embed strong… more
- Merck & Co. (Rahway, NJ)
- …in design controls, ISO 13485, deviation management, change control , risk management/ISO 14971-2019 and the fundamentals of documentation structure/systems- ... in medical device, pharmaceutical or in biotech organizations Five plus years in design control , risk analysis and change control management for medical… more
- Novo Nordisk Inc. (Durham, NC)
- …on shop floor Ability to support all processes & functions in Department Quality Risk Management Make decisions on quality & compliance issues with little ... of four (4) years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation required Excellent troubleshooting… more
- Merck & Co. (Rahway, NJ)
- … documentation in support of the following: process characterization (PC), risk assessment (RA), control strategy, comparability reports, and/or regulatory ... bank best practices across the network.Author required regulatory and technical documentation associated with cell bank process transfer, long term storage… more
- Merck & Co. (Rahway, NJ)
- …Driving License:NoHazardous Material(s):n/aRequired Skills:Audits Compliance , Audits Compliance , Compliance Program Development, Currency Risk ... Proof of Payment activities. CIT is primarily responsible for determining trade compliance requirements and processes, as well as executing select trade … more
- Merck & Co. (Rahway, NJ)
- …Drug Product and Clinical Finished Goods).-- Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as ... supply chain documentation to support critical CMC activities.- Responsible for authoring...Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, &… more
- Merck & Co. (Rahway, NJ)
- …across programs.Technical scope:Direct projects focusing on cell bank process risk assessments, documentation , process characterization, technology transfer and ... identification and implementation of process changes for replenishment lots, control strategies, manufacturing operations, investigation evaluations, and regulatory filings.Design,… more
- Merck & Co. (Rahway, NJ)
- …Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, Strategic ... estimates requested by Product Development Teams.-Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as… 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 ... will provide hands on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices… more
- Eisai, Inc (Raleigh, NC)
- …to increase efficiency and effectiveness of the complete supply chain and minimize risk of obsolescence or supply interruptions.Ensure full compliance with all ... SCM Unit will lead a cross-functional team driving excellence in Import/Export Compliance , Logistics, and Supply Chain support while interfacing closely with other… more
