- Merck & Co. (Millsboro, DE)
- …of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create ... patients on time, every time, across the globe.The Quality Control (QC) Associate Specialist, with Guidance from the QC... (QC) Associate Specialist, with Guidance from the QC Manager , ensures product/process quality through the review of GMP… more
- Merck & Co. (Rahway, NJ)
- …CRA (Clinical Research Associate) manager and/or functional vendor and internal management as-needed.Performs Quality control visits as required.Leads local ... and adverse event reporting-requirements internally and externally.The CRM (Clinical Research Manager ) could be responsible for a particular study for several… more
- Eisai, Inc (Nutley, NJ)
- …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 ... validation. Support computer system audits for review of SDLC and data integrity controls . Review CAPA and verification of CAPAs of system audits. Support health… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... aspects related to Quality Systems, Finished Product Batch Release, Change Control , Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of… more
- Merck & Co. (North Wales, PA)
- …with and provide oversight/direction to Suppliers and communicate with internal cross-functional teams to share project status and mitigations.Track ... timelines/deliverables and follow up on action items (Supplier and internal teams/scientists).Maintain key study information in applicable system(s) and manage… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure all systems are operating well as designed. Ensures compliance with internal controls and accounting policies. Optimizes Financial Disbursement technology ... through system upgrades and other proven automation practices to build efficiencies and stay ahead of the latest technological trends. Works closely with Finance, Procurement, Legal, IT and other departments, as required. Increased focus will be placed on… more
- Merck & Co. (North Wales, PA)
- …Contracting and Distribution Strategies team in US Vaccines is seeking a Customer Manager who will be responsible for managing our contracts and agreements in the ... Public Sector (inclusive of Centers for Disease Control and Prevention , United States Department of Veterans Affairs , and Department of Defense segments).-This… more
- Catalent (St. Petersburg, FL)
- …limited to Quality Systems, Finished Product Batch Release, Training, Internal /External Audits, Complaints, APR, Investigations, Document Control , ... Control , etc. The focus of each QA Manager may be dependent upon the needs of the...and communicate requirements to site leadership.Review and approve change controls related to local GxP systems.Review and approve periodic… more
- Catalent (St. Petersburg, FL)
- …Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control .The QA Product Manager provides customer service, with the highest ... QA Product Manager Position SummaryThe QA Product Manager ...compliance with partnership with Catalent St. Petersburg's customers and internal organizations. This position serves as a representative for… more
- Novo Nordisk Inc. (Durham, NC)
- …on Quality. Coordinates with contractors, engineers & other providers as well as internal stakeholders for the success of the Site. Relationships Manager , FUSE. ... Manage any safety, quality, staffing or personnel issues & escalate to manager as necessary Ensure documentation meets GMP requirements Lead & manage maintenance… more
- Merck & Co. (Durham, NC)
- …manufacturing/work environments Meeting Facilitation/Training/Presentation SkillsPlanning, Implementing, Directing, Control , Decision Making-NOTICE FOR INTERNAL ... Injection (WFI), and Clean Steam (CS))Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)Maintenance Equipment… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …accordance with established policies and procedures, develop proposals, implement project controls , facilitate and manage effective internal and external client ... Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract… more
- BioAgilytix (Durham, NC)
- …a variety of project support through all phases of our client services. As a Project Manager I, you will be the glue connecting our internal functions to the ... you'll be right at home here at BioAgilytix.Essential ResponsibilitiesPartner with internal and external stakeholders to define project timelines, ensure projects… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …procedures and/or systems to improve organizational efficiencies and cost controls .Communication and Relationship Management - Leads contract related communication ... with vendors. Respond to questions from internal staff regarding status of contracts. Interacts with vendors...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- BioAgilytix (Durham, NC)
- …post-market product changes and decision on appropriate mechanism for change control (eg internal documentation, notification of change, supplemental ... life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects… more
- Eisai, Inc (Nutley, NJ)
- …functions and compliance controls .Monitor and test IT compliance controls for effectiveness.Remediate control deficiencies and investigate potential unlawful ... Manager (CISM), Certified in Risk and Information Systems Control (CRISC), Certified Information Systems Auditor (CISA), or other similar credentials.Strong… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related ... priorities.Anticipate upcoming tasks based on the submission timelines.Perform quality control checks and coordinate comment resolution with publishing team.Support… more
- Catalent (St. Petersburg, FL)
- …aspects related to Quality Systems, Finished Product Batch Release, and Change Control .II. Basic Function: This position is responsible for managing and documenting ... Standard Operating Procedures through the periodic inspections and monitoring of process controls in all applicable areas of the manufacturing operation. The Senior… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead ... auditor Works closely with Manufacturing and Quality Control to resolve open issues resulting from record... to resolve open issues resulting from record reviews, internal audits of the facility, and deviation issues Performs… more
