- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the scope of the COE Develop and leverages relationships with HQ SMEs, process management , and system management to influence process and system ... quality representatives and/or contingency workers. Essential Functions Deviation Management Develops and serves as Quality Point...in the development and/or implementation of processes and programs System Management Acts as SME for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the scope of the COE Develop and leverages relationships with HQ SMEs, process management , and system management to influence process and system ... and NAO Quality Department as needed and assigned by NAO Quality Management Attend relevant symposia, conferences and scientific meetings, as necessary… more
- Merck & Co. (Rahway, NJ)
- …Capital Projects, Collective Bargaining, Compliance Assurance, Computerized Maintenance Management Systems (CMMS), Digital Transformation, Driving Continuous ... energy efficiency, and compliance.Lead root cause analysis and corrective/preventive actions ( CAPA ) related to HVAC system failures or deviations.Monitor and… more
- Aequor (Houston, TX)
- …the most likely cause of the deviation investigation o Familiarity with cGMP quality systems , and demonstrates ability to read and comprehend GMP documents ... M-F 1st Shift on-site 5x/week Responsible for tracking, management , and completion of Supply Chain Quality...cause of the deviation investigation Knowledge Familiarity with cGMP quality systems , and demonstrates ability to read… more
- Aequor (Houston, TX)
- …of varying difficulty. Attendance and occasional leadership of the daily management system and participating/leading the deviation review board. Perform ... deviations with the aim at identification of root cause, determining Product Quality Impact (PQI) and implementation of corrective actions to prevent recurrence.… more
- Repligen (Waltham, MA)
- …of 10 years of experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.Minimum 5-8 years of experience mentoring ... create and revise procedures, practices, and specifications; provide training on quality system and procedures.Maintain strong cross-functional quality … more
- Merck & Co. (Durham, NC)
- …License:NoHazardous Material(s):n/aRequired Skills:Building Automation Systems , Computerized Maintenance Management Systems (CMMS), Electrical System ... developing/performing PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality improvement initiatives for development activities / programs post internal system audit.Support reporting of quality metrics for audits and ... management support regarding compliance concerns identified during internal systems audits, remediations implemented and CAPAs pending.Support Risk Mitigation… more
- Merck & Co. (Rahway, NJ)
- …( CAPA ).- Facilitate equipment/ system changes, execute periodic reviews and support Quality Management System (QMS) activities.- Interface with site & ... (PHA), Process Optimization, Project Management System , Quality Management , Quality Management System Improvement, Reliability Management… more
- Merck & Co. (Rahway, NJ)
- …will: Execute solutions to business needs by designing and implementing new data management systems Employ innovation and technology solutions to manage data ... Business Intelligence Development, Business Process Automation, Business Processes, Business Process Management (BPM), Business Support, CAPA Management ,… more
- AUROBINDO (Durham, NC)
- …pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and ... shipping documents as required.To perform all entries in ERP system related to the department.To write the deviations and... related to the department.To write the deviations and CAPA for the departmental activities.Perform any and all additional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … quality teams to support GRA meeting company policies for quality management (eg, completing requests/initiatives from the GSOP Committee)Proactively manage ... Engineering, Statistics, or related field required Experience:4 or More Years Experience in quality management in the pharmaceutical industry and quality … more
- Fresenius Medical Center (Waltham, MA)
- …CAPA process and tool integration of all requirements from CQMS, IMS, and NA quality management systems + Conduct process design & development, document ... appropriate strategy to implement all necessary requirements from FME Quality Management and formerly used NC/ CAPA... system is successful and compliant. Partners with Quality Systems personnel and responsible for driving… more
- Terumo Medical Corporation (Somerset, NJ)
- …Details/Responsibilities** + Support the management and effectiveness of the Quality Management System , primarily the CAPA system by: + ... & Compliance **Job Summary** The Quality Systems Engineer II drive TMC's Corporate CAPA ...understood appropriately incorporated into CAPA documentation and Management Review + Generate Quality System… more
- DEKA Research & Development (Manchester, NH)
- …+ Experience with Corrective and Preventive Action ( CAPA ) + 1+ years' experience in quality systems management , CAPA , quality assurance or a ... to understand and provide guidance on quality system procedures + Project coordination/ management skills + Technical Writing experience + Excel, Word, Visio… more
- Teleflex (Chelmsford, MA)
- …manage, and drive improvement in 5 main areas of the Quality Management System including CAPA & Nonconformance (NC) Processes; Incoming Inspection ... and/or related manufacturing/engineering role, prefferably in a manufacturing site. * Quality system management and deployment experience preferred. *… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …of Responsibilities** + Leads a team of specialist that support the Quality Management System , including the CAPA and internal audit processes. + ... may provide leadership for multi-disciplinary projects + Considered Site Quality Management System Subject Matter...working in a design center. **Knowledge and Skills:** + Quality Management Systems requirements for… more
- Actalent (Lawndale, CA)
- …We are seeking an experienced Quality Manager to lead and maintain our Quality Management System (QMS) in compliance with FDA and other regulatory ... + Root cause analysis + Medical device industry experience + CAPA + Quality management + AS9100 + Quality management system Additional Skills &… more
- Church & Dwight Co., Inc. (Princeton, NJ)
- …and implementation of a technical QMS area CAPA ) of Church & Dwight's global Quality Management System for all Church & Dwight sites globally. The ... to the Global QMS Head (change control, document control/training, CAPA , validation), the Global Quality Area Head...and lead root cause analyses to address and resolve CAPA system and process-related challenges. + Work… more
- DEKA Research & Development (Manchester, NH)
- Join our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Quality Systems Engineer, you'll be a key player in our ... quality and compliance. Key responsibilities as a Quality Systems Engineer: + Own and manage...CAPA documentation aligned with regulatory requirements and risk management . + Track CAPA trends and metrics… more
