- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is ... delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and...analytical skills and report writing skills Experience with GxP systems including computer system validation and associated… more
- Cytiva (Muskegon, MI)
- …career.Learn about the Danaher Business System which makes everything possible.The Quality Assurance Engineer will be the subject matter expert for the ... and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into...Muskegon site Validation Master Plan.This position reports to the Quality Assurance Manager and is part of… more
- Beckman Coulter Life Sciences (Indianapolis, IN)
- …the Danaher Business System which makes everything possible.The Staff Quality Assurance Engineer or Scientist is responsible for facilitating application ... of quality system and design control processes with...you will have the opportunity to:Representing quality assurance on development teams, quality systems… more
- Aequor (Aliquippa, PA)
- …vendors to ensure successful operations Participate / Conduct quarterly Business / Quality reviews and address service failures with the LSP Ensure metric targets ... engineering activities Experience in deviation, change controls, and CAPAs processes system knowledge Ability to evaluate compliance issues and interact with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …properly investigated and that technology-related audits are conducted.Oversee and guide quality assurance processes related to project specifications, ensuring ... standards are met.Proactively assess and address operational gaps related to quality systems and compliance, fostering a culture of sustainable… more
- Merck & Co. (Rahway, NJ)
- …challenges, balancing effective operations with transformative initiatives.- The Associate Director, Quality System & Compliance will support to integrate the ... of medical devices or medical device combination products with experience in quality assurance or regulatory oversight of these products.Experience authoring,… more
- Tris Pharma (Monmouth Junction, NJ)
- …(QMS). Title commensurate with experience.Summary:This position supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality ... guidelines, standards and objectiveOversees and manages maintenance and tracking of Quality Systems including, but not limited to: Investigations/OOS/OOT/Lab… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and in a manner which meets their expectations Coordinates and collaborates with Quality Assurance function to maintain a COE for deviation management covering ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....and leverages relationships with HQ SMEs, process management, and system management to influence process and system … 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 ... processes involved in quality analytical labs, validation, manufacturing, quality assurance , process development and distribution. 8. Extensive knowledge… more
- Cytiva (Miami, FL)
- … Specialist is responsible for ensuring the integrity of environmental monitoring, quality control testing, and sterility assurance processes in a highly ... belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at… more
- Twist BioScience (South San Francisco, CA)
- …MES professionals, primarily software developers, who work in concert with Manufacturing Operations, Quality Assurance , and R&D. The Director will serve as the ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance , Process Development, and Regulatory Affairs teams… more
- BioAgilytix (Durham, NC)
- …for data quality , access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory ... ERP systems .Proven ability to define data standards, develop and implement quality assurance processes, and ensure data integrity in alignment with… more
- AUROBINDO (Durham, NC)
- …and approve validation deliverables associated with various Aurolifesystems such as LIMS, Quality Assurance Management System (QAMS),Waters Empower, Document ... family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance , Quality control, and regulatory affairs. In… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThis role is key leadership position within Global QMS and Global Quality Assurance . Overall accountability is develop strategic framework work for ... at least 5 plus years of experience within progressive GxP- Quality Assurance or equivalentMust have a minimum...matrixed global teams environmentMust have a broad understanding of quality management system , GxP regulations and industry… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Confirm final profile and submit in Zycus for SAP creation.As relevant, liaise with the Quality Assurance group to obtain QA risk rating and audit status for RDP ... up-to-date evaluations. Review and update questions and pending statuses with the Quality Assurance group on a regular basis.Qualifications Successful candidates… more
- Aequor (Tampa, FL)
- …with pharmaceutical industry preferredStrong background in Quality Management Systems , Compliance or Quality Assurance preferredExperience in ... Have List:Bachelor's Degree4&plus years of Audit ExperienceHighly Preferred:Biopharma experienceQuality Assurance experience Purpose and Scope of Position:This role supports… more
- Eisai, Inc (Raleigh, NC)
- …should include a global bio/pharmaceutical background including close collaboration with Quality Assurance , significant interface experiences with the Finance, ... (SCM) Unit is accountable and/or responsible for providing an uninterrupted supply of quality products to patients and DCU customers in their respective regions. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the ... meetings, remediation and risk management in close collaboration with the organization's quality management system , to assure robust knowledge transfer and… more
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