- Catalent (St. Petersburg, FL)
- …Internal/External Audits, Complaints, APR, Investigations, Document Control , Equipment/Facilities, Change Control , etc. The focus of each QA Manager may be ... to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support… more
- Catalent (Harman, WV)
- The Manager , Supply Chain - Warehouse , reporting to the Director, Supply Chain, has an opportunity to make a significant impact on the way that the Harman's site ... operates. The Manager , Supply Chain - Warehouse will lead a shift...Warehouse will lead a shift consisting of Warehouse Materials Control Associates and Materials Services Associates. Responsibilities include: project… more
- Merck & Co. (Durham, NC)
- …Injection (WFI), and Clean Steam (CS))Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)Maintenance Equipment ... in complex manufacturing/work environments Meeting Facilitation/Training/Presentation SkillsPlanning, Implementing, Directing, Control , Decision Making-NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers'… 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
- 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)
- …timeline, budget and objectives set forth by the Study team.The Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate ... in accordance with DS standards. Act as the project manager of the clinical study team to liaise and...and site level documents to the Daiichi Sankyo Document Control Center (DCC) in support of the Trial master… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …production engineers in development of metrological specifications for new equipmentDevelop control charts and statistical process controls for calibration ... maintain metrological traceability for laboratory measurement parametersThorough knowledge and application of measurement uncertaintyAbility to develop, document, and implement… 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 ... execute the outsourcing process. Responsible for appropriate utilization and application of advanced negotiation skills, partnership management and strong… 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
- Merck & Co. (Durham, NC)
- …biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Senior Specialist will assist with ... master batch records executed records, technical protocols, investigations, change controls , SOPs, Work Instructions, Job Aids, validation protocols, and technical… more
- Merck & Co. (Rahway, NJ)
- …any related corrective action/preventive action (CAPA).- Facilitate equipment/system change controls , execute periodic reviews and support Quality Management System ... as required. Create and manage lockout/tagout and hazardous energy control procedures.- Support mechanical aspects of clinical operations, including… 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)
- …the direction of the QC Manager . Relationships Reports to: Quality Control Manager Number of subordinates with direct/indirect referral: no direct reports ... This position has primary responsibility to support operations for Quality Control at our biologics manufacturing facility. Assists in coordination and execution… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position This position is responsible for providing support to the Senior Manager and Director of Institutional Contracts by leading the team through the ... for all non-retail channels consistent with the agreement terms, corporate controls , and Sarbanes-Oxley regulations. Relationships Reports directly to the Senior … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate ... monitoring equipment), processes and applicable procedures.Knowledge of FDA regulations, application of Good Laboratory Practices, application of Good… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …expertise with information security threats, vulnerabilities, risks, and mitigating controls . This position will require an understanding of enterprise technologies ... such as networks, operating systems, application architecture, and cloud service models. They will be...systems and will assist with identification and documentation of controls to protect these systems. Relationships This position reports… more
- Merck & Co. (Rahway, NJ)
- …implement, and automate integrations with other tools, technologies, security controls , governance processes, and compliance validation.Develop a library of ... true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to… more
- Merck & Co. (Durham, NC)
- …biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion. ... performance objectives.Consults on an as-needed basis with next level manager on more complex decisions.Education Minimum Requirement:Bachelor's and/or Master's (or… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... Equipment (eg washers, autoclaves, tube welders/sealers).Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics).Clean-In-Place (CIP)… more
- Merck & Co. (Durham, NC)
- …osmosis skids, compressed gas systems) Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC))- Clean-In-Place (CIP) Systems- ... are guided by policies, procedures and business plan; receives guidance from manager . Contributes to the performance and results of the department. Identifies and… more
