- Catalent (St. Petersburg, FL)
- …and metrics, including DRB (Deviation Review Board) presentation.Effective communication with Quality Assurance Supervisor and Manager regarding status ... I. Department Overview: The Quality Assurance Department is responsible for...in all applicable areas of the manufacturing operation. The Senior QA Specialist will assist in organizing… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance ... and could include all or some aspects of the Quality function.The Product Development QA Manager... Manager is responsible for the overall Quality Assurance review and approval of all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily...for Operational Study Strategy. This position may require the Sr . CSM to take the role of both operational… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Essential Functions QA approver for internal computer system validation efforts. Act as liaison to the business ... for guidance and consultancy on system validation. Support computer system audits for review of SDLC and data integrity controls. Review CAPA and verification of CAPAs of system audits. Support health authority audits/inspections for inspection readiness.… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... improve team engagement & performance Drive Mdev LCM and QA requirements at the site ensuring a high level...processes and roles are established and capable to meet quality specifications & requirements, to include GMP Compliance of… more
- Tris Pharma (Monmouth Junction, NJ)
- … Manager , Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance ( QA ) Investigations and Product Quality Complaints ... and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …support of commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy the ... quality and process validation requirements for existing products. Participate...and EU requirementsCollaborate with peers and stakeholders to in QA and Manufacturing to identify opportunities for process improvementFacilitate… more
- Novo Nordisk Inc. (Boulder, CO)
- …to the overall operation. Relationships Specialist, API Manufacturing reports to the Senior Manager , API Manufacturing. The Specialist, API Manufacturing works ... Development, Analytical Services, Engineering, Facilities, EH&S, Program Management and Quality Assurance . Essential Functions Responsible for the manufacture… more
- Johns Hopkins University (Baltimore, MD)
- … Sr . Design & Construction Project Manage Job Posting Title (Working Title): Sr . Manager , Quality Assurance , Design & Construction Role/Level/Range: ... Recruitment Director ### ###@hays.com We are seeking a **_Sr. Manager , Quality Assurance , Design &...activities. + Assure Constructor has established and maintains a QA /QC process and reporting and review same on a… more
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