- Merck & Co. (North Wales, PA)
- …to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality ... and other worldwide regulations and our Compa requirements.This position provides Device quality engineering and quality assurance support and leadership… more
- Aequor (Thousand Oaks, CA)
- …submitted candidates DAY & SWING SHIFT This position supports 's Quality Assurance program under the Plant QA organization providing daily oversight of the ... of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate ...will also represent functional area for the Drug Substance Quality Assurance department in the execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality , and in close collaboration with the QA Training and Documentation ... and operations.- Supports Head Global Strategy and Operations for Global RD/PV/MA QA relevant activities including QQR, monthly quality report, team building… more
- Aequor (Athens, GA)
- …and regulatory requirements. Responsible as an approved USDA sampler and providing Quality Assurance and Production support as needed. Sample Life Cycle ... - 7:30am or 8:00am to 4:00pm or 4:30pm The Associate , Quality Control Data will manage the...release functions across different areas at the Athens site ( Quality Control, Quality Assurance , and… more
- Merck & Co. (Durham, NC)
- …the globe.This is a night shift P1 position on the 2/2/3 schedule. The Shop Floor Quality Assurance Associate is responsible for all Quality related ... actively participating in and embracing an empowered team culture.-The Shop Floor Quality Assurance Associate is responsible/accountable for Quality … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …document. Confirm final profile and submit in Zycus for SAP creation.Additionally, Liaise with Quality Assurance group to obtain QA risk rating and audit ... vendor for up-to-date evaluations. Review update questions and pending statuses with Quality Assurance group on a regular basis. Qualifications: Successful… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas (eg clinical research & development, clinical science, clinical quality assurance , project management) preferredStrong leadership, collaboration, ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …PV QA strategy in close collaboration with the VP, Global head of Quality Assurance (RD/PV QA ). CAPAs Ensure adequate CAPAs are defined, implemented, ... business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise... reports QQRs and or assigned by VP Global Quality Assurance (RD/PVQA) delivered in a timely… more
- Aequor (Thousand Oaks, CA)
- …leadership, International Quality , Quality Control, Contract Manufacturing Quality , Regulatory, Process Development, Quality Assurance , and other ... data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for a product team...the champion for a product team as the Product Quality Leader (referred to as PQL), providing technical expertise,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functions (eg clinical research & development, clinical science, clinical quality assurance , project management) requiredStrong leadership, collaboration, ... and establishes a comprehensive interface for risk and issue management.Support GCO Quality by Design, risk management, issue management, and root cause analyses.As… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Affairs, Sales/Marketing, Managed Markets, Pharmacovigilance, Supply Chain, Compliance, Quality Assurance , pharma-specific litigation issues, promotional brand ... other research areas centered around rare diseases and immune disorders.Summary The Associate Director, Privacy & Compliance Investigations, is a member of the… more
- Merck & Co. (Durham, NC)
- …pushing and pulling;Ability to lift up to 50 pounds. Preferred Experience and Skills: Quality Control, Quality Assurance and/or cGMP experience.NOTICE FOR ... Job DescriptionPosition Description: Specialist, Quality Operations Environmental MonitoringSpecific to Environmental and Utility Monitoring, the analyst will be… more
- Merck & Co. (Rahway, NJ)
- …support investigations and provide expert opinions or technical assistance as needed. Quality Assurance and Compliance:-Develop and implement protocols and ... and experienced professional to join our team as an Associate Director for our Digital Forensics Lab. The ...and ensure the lab maintains a high standard of quality and accuracy.Digital Forensics Investigations:-Conduct and oversee complex digital… more
- Aequor (Thousand Oaks, CA)
- …4&plus years' experience in GMP / GDP compliance Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice. ... guidelines, giving consideration to usability and ensuring accuracy, consistency and quality . Maintain data accuracy and perform data analysis for Management reviews… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of ... risks is recognized and the need for CAPAs or reports on deviations is clearly understood. Basic knowledge of Import/export requirements to the extent that there is overall recognition of global differences exist and understanding of the need to address such… more
- Insmed Incorporated (Bridgewater, NJ)
- …substance sections of regulatory filings and dossiers.Sound awareness of Regulatory, Quality Assurance , and cGMP requirementsHigh energy, innovative "can do" ... for technical support as Insmed's internal SME, technical review of quality documentation, management of schedule/raw material consumption/budgets, and management of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the... of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relationships with internal and external stakeholders. Coordinate with lab units, SC, RACMC, QA to drive collaboration and solves issues in Tech Mgmt. (mAb, Drug ... Substance, Drug Product, or New Modality) team.- Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory questions, briefing books. Qualifications: Successful… more
- Merck & Co. (Rahway, NJ)
- …closely with leaders and scientists within Discovery, Pre-clinical Development, Manufacturing, Quality Assurance and Regulatory groups and provides technical ... Maintains productive communications with staff, colleagues across CMC development, Quality Assurance , and CMC Regulatory Affairs as needed… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support to the development team during implementation and participates in testing and quality assurance to ensure compliance with regulatory requirements such as ... to apply/integrate to policies and assists in the development of data migration, integration, and quality projects based on business needs. Provides guidance and… more
