- Novo Nordisk Inc. (Plainsboro, NJ)
- …with robust root cause analysis utilizing Standard Problem Solving (SPS) methods and strong CAPA development within the NN deviation IT platform Serve as chair of PV ... Specific or technical job skills Strong Root Cause Analysis and CAPA development skills. PV experience/knowledge preferred Excellent interpersonal skills and ability… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …coordinate, and manage root cause analysis, corrective action(s)/preventative action(s) ( CAPA ) in connection with audit and/or inspection responses, and ensure ... proper implementation across various areas of the business Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or implementation of processes and programs Maintains current understanding of laws and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities ... the execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections across...and that evidence is archived.Ensure up to date audit CAPA information in the eQMS in a timely manner.Support… more
- Aequor (Houston, TX)
- …of Supply Chain Quality Records (such as deviations, material recalls, and CAPA ) in partnership with applicable SMEs. Leads error prevention and continuous ... customer satisfaction within the scope of their role under guidance of supervisor/ manager o Generously shares information and knowledge with others across the team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... years with experience coordinating and managing regulatory audits and inspections, incl. CAPA management (Prefered). Travel: Ability to travel up to 10% Business… more
- Merck & Co. (Rahway, NJ)
- …reporting, investigations, and any related corrective action/preventive action ( CAPA ).- Facilitate equipment/system changes, execute periodic reviews and support ... Project management.-Track-record of independent problem-solvingSAP Training and skills - Project Manager (PM) role, SAP Plant Maintenance (Gatekeeping and Work Order… more
- BioSpace (New York, NY)
- …needs via oral or enteral routes. Job Overview: The Clinical Trial Manager (CTM)/Clinical Research Associate is responsible for providing oversight of the Sponsor's ... and review respective reports related to site issues and contribute to CRO CAPA development, as required. Review and contribute to CO sections of Clinical Study… more
- Gossamer Bio (San Diego, CA)
- …invoices, customs declarations, packing lists). Support deviation investigations and CAPA activities related to logistics operations. Ensure compliance with Gossamer ... policies, safety standards, and global regulations. Collaborate with stakeholders to implement portfolio-focused logistics strategies that optimize cost, timelines, and compliance. Lead 3PL and vendor selection, qualification, and performance monitoring. Help… more
- elf Beauty (New York, NY)
- …Product Quality (MPQ) related incidents with various functions through effective CAPA . Coordinate Quality topics with our Canadian distributor to mitigate any ... to Active Pharmaceutical Ingredients (API). Travel as needed. Partner with the QMS Manager to develop a global QMS, maintain, and fine-tune with matching elf… more
- Abbott (Minneapolis, MN)
- …management solutions for treating structural heart disease. As the Senior Program Manager , R&D, you'll have the chance to be responsible for cross-functional team ... business unit and divisional strategy planning. Participates in review boards for CAPA , complaints, business unit planning, and others as necessary. Reviews and… more
- Beacon Engineering Resources (Wethersfield, CT)
- Quality Systems Manager Position Overview: We are seeking a Quality Systems Manager to lead the development and oversight of our Quality Management System (QMS), ... champion continuous improvement efforts. Conduct root cause analysis and oversee CAPA (Corrective and Preventive Action) processes. Ensure adherence to applicable… more
- Michael Page (Wood Dale, IL)
- …the last 10 years. They are currently looking to bring on another Quality Manager to help their expanding business, specifically as they get more involved in the ... teams Excellent problem solving skills and ability to conduct root cause and CAPA Knowledge of SPC and experience with quality management software CMM programming… more
- CMA CGM (Chicago, IL)
- …Devices and Pharma Industry Quality Standards ( Iso 9001, GDP,GMP,ISO 13485) CAPA , NC, Audit Management Drive for Results Action oriented Decision Maker Customer ... focus Motivating Others Ability to communicate at all levels in the internal organization , with customers, Regulatory authorities, suppliers, etc. Experience working in a Matrix organization before. WHAT DO WE HAVE TO OFFER? With a genuine culture of… more
- The Fresh Factory (Carol Stream, IL)
- …main liaison between QA and Operations. This role reports to the Quality Assurance Manager . This is a first shift role and will be operating independently, a ... GMP adherence Preform Process Reviews Be a front line investigator for Quality Complaints, CAPA / Internal Audit Program Be the Operations to QA liaison for all… more
- Abbott (Altavista, VA)
- …help nourish millions of families around the world. The Food Safety Manager will be responsible for establishing and maintaining best-in-class food safety culture ... preventative controls of hazards, and investigation management. The Food Safety Manager will develop strong partnership with supply chain in conjunction with… more
- Kelly Services (Wilsonville, OR)
- …for extended periods. - Strongly Preferred: - Experience with FedEx Ship Manager , UPS WorldShip, DHL Easyship, and other online booking systems. - Familiarity ... work in ISO, GMP, and LEAN manufacturing environments. - Training in CAPA , HAZMAT, Chemical Hazards, Forklift, and Safety. Opportunities: This role offers… more
- Lonza (Portsmouth, NH)
- …in the life sciences industry? Lonza AG is looking for a QA Manager - Raw Materials Compliance who demonstrates dedication to lead our hard-working team ... to assess and resolve higher-risk issues with Change Controls, Deviations, CAPA , and Investigations Manage and track Key Performance Indicating Quality Metrics;… more
- ProCaps Labs (Henderson, NV)
- POSITION SUMMARY The Production Engineering Manager will lead a team focused on improving manufacturing processes, optimizing production efficiency, and ensuring ... to eliminate defects and maintain product quality. Actively participate in CAPA (Corrective and Preventive Action) meetings to address production deviations. Team… more
- LanceSoft (Pittsburgh, PA)
- …: 675 Kendall St 02147 Cambridge MA (Hybrid: 2x per week) Job Title: Senior Manager , Global Pharmacovigilance (PV) Quality Assurance Pay Rate : $ 105.00 to $ 110.00 ... interacts with cross-functional teams. Summary of Key Responsibilities: Senior Manager , PV QA supports all the GVP QA's responsibilities...tools and develop PV audit schedule. Provide QA Audit, CAPA and Supplier data for the PV System Master… more
- Takeda Pharmaceutical Company Limited (Round Lake, IL)
- …computer system validations. You will report to the Quality Validation Manager . How you will contribute: Quality Systems/Document Control: Owns Standard Operating ... in the execution of risk management activities. Deviations and CAPA : Owns investigations and CAPAs relevant to responsibilities/expertise. Approve investigations… more
