- Merck & Co. (Rahway, NJ)
- … (SAP), Document Management Systems (Veeva Vault), Supplier Management Systems , etc.Support MDCP sites with new/revised QMS Quality Standards and/or ... be able to build relationships within a team environment.Experience using computer systems for Quality Management Systems .Must have working knowledge… more
- Tris Pharma (Monmouth Junction, NJ)
- …guidelines, standards and objectiveOversees and manages maintenance and tracking of Quality Systems including, but not limited to: Investigations/OOS/OOT/Lab ... and product quality complaintsEngages in activities to continuously assess/improve quality systems by identifying and proactively resolving quality … more
- Cepheid (Miami, FL)
- …waiting.Learn about the Danaher Business System which makes everything possible.The Senior Quality Systems Specialist is responsible for functioning as Lead ... and implement improvements. This position will work with the Senior Manager Quality Systems Compliance.This position is part of the Quality department and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Quality Assurance Group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed ... aligned with our high standards of quality and meets all regulatory requirements. Partnering across our...Compliance will report to the head of the Global Quality Compliance Support organization.- The responsibility of this position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … standards are met.Proactively assess and address operational gaps related to quality systems and compliance, fostering a culture of sustainable ... validation of IT services and determining audit targets for GxP systems .ResponsibilitiesLeadership and Strategic DirectionThe Sr. Director, Data Quality and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …take on multi-disciplined projects, with minimal supervision Functional understanding/application of quality systems with the ability to manage Change Controls ... The Position This position has primary responsibility to support operations for Quality Control. Assists in coordination and execution of process and equipment… more
- Aequor (Thousand Oaks, CA)
- …change requests approved by management. 4. Work within the Information Services and Quality Systems teams to foster good communication throughout the project ... possible remote role Summary: Under general direction, functions as the Specialist Quality Control working at the Corporate QC Center. Description: Job Details:… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …will have the opportunity to:Representing quality assurance on development teams, quality systems and product improvement projects for Beckman Coulter Life ... Science.Coaching teams with application of ISO 9001/13485/cGMP/IEC 62304 and quality systems processes throughout product lifecycle.Partnering cross functionally… more
- Cepheid (Miami, FL)
- …everything possible.The Sr. Quality Specialist is responsible for supporting quality systems activities related to assay development, specially design ... would be a plus if you also possess previous experience in: Quality Systems / Quality Engineering background in molecular biology products or molecular… more
- Beckman Coulter Diagnostics (Miami, FL)
- …engineering or supplier development within international manufacturing environments.Deep expertise in quality systems and tools, including risk management, CAPA, ... address the world's biggest health challenges. The Global Supplier Quality Engineer - Metals for Beckman Coulter Diagnostics will...for Beckman Coulter Diagnostics will serve as a critical quality liaison between Beckman Coulter and our key metals… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …& relevant processes. Ensures alignment of training processes to corporate & quality systems . Responsible for maintaining Standard Operational Procedures (SOPs) ... Extensive knowledge in training principles, knowledge management, and instructional systems design preferred Knowledge of pharmaceutical manufacturing quality … more
- Novo Nordisk Inc. (West Lebanon, IN)
- …on and manage multi-disciplined projects, with minimal supervision Understanding/application of quality systems Support of Health Authority inspections Possesses ... and execution of process and equipment improvement initiatives, reviews completed quality records, generates quality deviation responses, drive investigations… more
- Merck & Co. (Rahway, NJ)
- …and maintain proficiency in ISO 13485, ISO 14971, and other relevant quality management systems . Qualifications: EducationRequired - Technical BS degree or ... verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance. Exceptional project management… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Generate or facilitate, as needed, document revisions related to Facilities or Quality systems Support scheduling and coordination of maintenance activities as ... The role also provides support to other Facilities related systems as directed. Incumbent will work closely with our...other needs as directed by supervisor Support resolution of quality system items ( quality notes, deviations and… more
- Repligen (Waltham, MA)
- …able to perform root cause analysis and generate corrective actions to improve processes/ systems .The position will develop Quality Control systems to ... OverviewThe Quality Control Supervisor will report to the QC...and concepts such Microbial Assays, Immunoassays, Analytical assays, Water systems , EM programs, etc.They will also be responsible for… more
- Merck & Co. (Rahway, NJ)
- …combination products, demonstrating a deep understanding of regulatory frameworks, quality management systems , and industry best practices.Exceptional strategic ... improvement.-Experience with autoinjectors, prefilled syringes, and other drug delivery systems , or equivalent is required.-Key needs for this role… more
- Merck & Co. (Rahway, NJ)
- …and supporting quality investigations and change management and experience with quality systems also required.Must have knowledge and experience of drug ... startup and operational readiness.Collaborate closely with the formulation scientists, engineers, quality representatives, and other team members to ensure the … more
- Repligen (Clifton Park, NY)
- …will play a key role in delivering the site expansion programs, implementing quality management systems and maintaining ISO certification. The individual will ... at the site, including Planning, Procurement, Manufacturing, Distribution, Engineering, Quality and Customer Service Order Processing.Hire Operations leadership team.… more
- AUROBINDO (Durham, NC)
- …protection standards.Support internal and external regulatory inspection activities related tovalidated systems .Provide support to Quality Programs such as Data ... expertise in reviewing and approving validation deliverables for key quality and laboratory systems such as LIMS, QAMS, Waters Empower, DMS, and Training… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …help the team, in a manner consistent with safety policies, quality systems , and cGMP requirements.Support manufacturing investigations, create/revise ... input on personnel performance.Build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production tasks and work… more
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