- Aequor (Tampa, FL)
- …with initiative to deliver timely resultsExperience with pharmaceutical industry preferredStrong background in Quality Management Systems , Compliance or ... experience Purpose and Scope of Position:This role supports the Market Research (MR) Compliance and Operations Team under direction and guidance from the MR … more
- Merck & Co. (Rahway, NJ)
- …testing, and process validation, with a strong understanding of quality management systems and regulatory compliance .Demonstrated technical experience in ... maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems .Qualifications:Bachelor's degree in mechanical engineering,… more
- Tris Pharma (Monmouth Junction, NJ)
- …Jersey, Tris has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This ... guidelines, standards and objectiveOversees and manages maintenance and tracking of Quality Systems including, but not limited to: Investigations/OOS/OOT/Lab… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … quality standards are met.Proactively assess and address operational gaps related to quality systems and compliance , fostering a culture of sustainable ... to quality standards in ongoing projects and processes.Coordinate with the Quality Management System (RDPVMA) teams to support the audit functions, including… more
- Genmab (NJ)
- …we would love to have you join us!The RoleThe Associate Director, External Data Quality Management , is a strategic leadership role within Clinical Data ... external vendor management a plus.Proven expertise in protocol design, data quality management , and protocol deviation oversight.Strong knowledge of EDC … more
- Aequor (Thousand Oaks, CA)
- …requests approved by management . 4. Work within the Information Services and Quality Systems teams to foster good communication throughout the project life ... cycle. 5. Ensure compliance - which includes implementing procedures that enhance GMP...of expertise. 15. Extensive knowledge and application of SAP Quality Management (QM) Module 16. Advanced skills… more
- BioAgilytix (Durham, NC)
- …and compliance .Develop a roadmap for building a high-performing data management team, identifying roles in data engineering, quality , and automation ... a foundational data governance framework, with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build … more
- Novo Nordisk Inc. (Durham, NC)
- …functions in Department Quality Risk Management Make decisions on quality & compliance issues with little guidance Participate in process group ... preferably in the pharmaceutical industry Demonstrated expertise in Regulations & quality systems (eg, commercial product disposition, DV/CAPA, Change Control,… more
- Aequor (Swiftwater, MN)
- …QC Instrument Support (QCIS) Description This position will support the lifecycle management of instrumentation within the Quality Control department at the ... Shift: 1st Work Schedule: 8AM - 4PM EST Mon-Fri Quality Control Technician II (Manufacturing/ Quality ) 1st Shift:… more
- Eisai, Inc (Raleigh, NC)
- …along with Eisai Canada, Mexico, and Europe for import and compliance management .Effective communication, relationship building, and strong partnerships are ... along with Eisai Canada, Mexico, and Europe for import and compliance management .Effective communication, relationship building, and strong partnerships are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes in support of clinical development objectives.- Accountable for lab data management deliverables for all programs meeting quality and time expectations ... for the oversight of CROs pertaining to laboratory data management , LNR collection standards, and quality issue...and Lab Load Templates.- Accountable for oversight for Data Management resources, CROs, and vendors to ensure compliance… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …PowerPoint, Excel, OneNote, Project, and Teams Requires demonstrated computer skills with data management systems or data bases Ability to utilize electronic ... as 120 VAC, 24 VDC, 480 VAC GAMP guidelines Computer Maintenance Management Systems (CMMS) Understanding standard operating procedures (SOP's) Physical… more
- Merck & Co. (Durham, NC)
- …training to mechanics and other maintenance personnel.Interface with safety, production, and quality groups to ensure facility operations and systems comply with ... and implementation of preventative and predictive maintenance programs to assure compliance with quality , regulatory, and reliability requirements and… more
- Merck & Co. (Durham, NC)
- …filtration skids, chromatography columns, washers, autoclaves, or Clean-In-Place (CIP) systems . Compliance and Documentation:Takes ownership of cGMP compliance ... requiring coach input and actively trains new team members to ensure suite compliance with SOPs.Business Systems Proficiency:Proficient in business systems … more
- Merck & Co. (Durham, NC)
- …activities while ensuring a safe work environment with optimized product quality and manufacturing processes and regulatory compliance .The Associate Director ... Principle, Engineering Standards, Estimation and Planning, General Safety, GMP Compliance , Identifying Customer Needs, Leadership, Maintenance Management ,… more
- Merck & Co. (Durham, NC)
- …, Good Manufacturing Practices (GMP), Lean Manufacturing, Manufacturing Processes, Problem Management , Process Automations, Quality Management , Real-Time ... technology systems , and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement,… more
- Merck & Co. (Durham, NC)
- …Communication, Data Management , Emerson DeltaV, GMP Environments, Problem Management , Quality Management -Preferred Skills:Job Posting End Date:06/20/2025 ... technology systems , and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement,… more
- Merck & Co. (Durham, NC)
- …Material(s):N/ARequired Skills:Adaptability, Adaptability, Allen Bradley PLC, Chilled Water Systems , Computerized Maintenance Management Systems ... GMP Compliance , Good Manufacturing Practices (GMP), HVAC Systems , Instrumentation, Interpret Electrical Drawings, Lockout Tagout, Maintenance Processes, … more
- Merck & Co. (Durham, NC)
- …License:NoHazardous Material(s):Cleaning suppliesRequired Skills:Adaptability, Adaptability, Calibration Management Software, Computerized Maintenance Management ... Systems , Engineering Design, Equipment Maintenance, General Safety, GMP Compliance , Good Manufacturing Practices (GMP), Manufacturing Processes, Mechanical Troubleshooting,… more
- Merck & Co. (Rahway, NJ)
- …Moulding, Procurement, Product Development, Product Lifecycle Management (PLM), Product Risk Management , Quality Management Systems (QMS), Risk ... regard for all of our Company divisional and local site procedures for safety, quality , and regulatory compliance - Understand the big picture, and how activities… more
