- Eisai, Inc (Exton, PA)
- …systems. The position will participate in site deviation investigations, change control and corrective action/preventative action process.Essential Functions ... want to hear from you. Primary responsibility will be to maintain the various control systems throughout the pilot plant facility as well as the laboratory building.… more
- Merck & Co. (North Wales, PA)
- …in process and equipment qualification & validation, root cause analysis, change control , deviation management, and cleaning qualification.-Expert grasp of ... processes including packaging equipment design & development, ensuring packaging process control and efficiency and providing on-going packaging and device technical… more
- Merck & Co. (Durham, NC)
- …SAP transactions, validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces an ... reverse osmosis skids, compressed gas systems)Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC))-Clean-In-Place (CIP) Systems-Maintenance… more
- Tris Pharma (Monmouth Junction, NJ)
- …Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including reviews/approvals of Change Control Reports (CCRs), methods, specifications, protocols and ... and reports, as well as test methods and proceduresPrepares CCRs, according to change control processCoordinates, advances and monitors progress for all required… more
- Merck & Co. (Durham, NC)
- …related projects, scope including but not limited to acquiring funding, change control , installation & integration, commissioning, and equipment ... to plant maintenance and spare parts procurement systemsProject management, including change control and equipment qualificationSAP experience related to plant… more
- Merck & Co. (Rahway, NJ)
- …to effectively identify and express risks Preferred Deviation management and change control processesAuthoring and/or reviewing technical documents to support ... of relevant industry knowledge in systematic development, validation, and/or quality control (QC) orMaster's degree in biology, chemistry, biochemistry, or related… more
- Merck & Co. (Durham, NC)
- …GMP compliant calibration and maintenance databasesProject management experience including change control and equipment qualification-Preferred Experience and ... Due Date Deviation (DDD), Out of Tolerance (OOT), and Engineering Change Request (ECR) activitiesEnsure an effective scheduling process execution. (Look-ahead, WOs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …including, but not limited to IQ/OQ/PQ, EMPQ, APS, PPQ, preferred.Experience with change management/ change control and quality systems.Experience with FMEA ... models to better understand and assess resource utilization, equipment utilization, change impact, etc.Support assessment of facility fitness, and design of facility… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …programs. Supports Quality driven initiatives related to facilities work such as change control , deviation, and corrective actions.Ensure collaboration with key ... facilities managementComputerized maintenance management systems (CMMS)Quality Management knowledge, including Change control , Deviation, and CAPA's.EHS and regulatory… more
- BioAgilytix (Durham, NC)
- …operating procedures including those for account management, workstation configuration, change control , application configuration, issues escalation, and ... to end-user service requests in a timely manner; completes requests to add/move/ change user accounts and workstations; addresses issues with corporate systems such… more
- Merck & Co. (Durham, NC)
- …with pharmaceutical industry technical business processes including:- technical documentation, change control , portfolio management, risk mitigation, deviation ... ApplicableShift:1st - DayValid Driving License:NoHazardous Material(s):n/aRequired Skills:Adaptability, Applied Engineering, Change Management, Clinical Manufacturing, Decision Making, Innovation, Interpersonal Relationships,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with global Sops. Lead the maintenance of signal tool and support tasks of change control , training material update, and end user support or process enhancement. ... management head, this individual will determine the necessity and validity of change requests and when required, perform user acceptance training.Ability to answer… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a GMP Commercial FacilityExperience with Commissioning/Qualification, Asset Change Control , Process/System Improvement, Asset Lifecycle ... (QI's). He/she supports CAPAs (Corrective and Preventive Actions) and CCs ( Change Controls) within quality management systems. You will also write SOPs… more
- Merck & Co. (Durham, NC)
- …pharmaceutical industry technical business processes such as:- technical documentntation, change control , portfolio management, risk mitigation, deviation ... management, technical protocols/reports, and BLA/MAA regulatory license documents.-Strong ability to collaborate and support teams across functional boundaries toward common goals.Ability to travel up to 10% in support of critical site needs.Preferred… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …documentation on the platform process description and collaborate to the global change control process and global investigations.Maintain global program project ... process platform changes/improvements in a global manufacturing network and drive change management process from inception through regulatory approval to global site… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Therapy cGMP manufacturing and project planning experience preferred.Provide technical expertise of Change Control process as well as oversight of the MES ... solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.Clear and succinct verbal and… more
- Merck & Co. (Durham, NC)
- …culture through continuous improvement activities- Assist Manager with facilitating shift change .- Performs inventory control and cycle counts. Resolves and ... management of samples handled within DurhamReview special communications at shift change to include 4-Quad.Executes room incursion initiation and approvals Assists… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …implementation in a GMP Commercial Facility.Experience with Asset Change Control , Process/System Improvement, Asset Lifecycle activities/documentation.Excellent ... knowledge of project management discipline and its application to drug product manufacturing required to deliver time, cost, quality, and risk management to teams.Experience with Healthy Authority requirements and regulatory submission activities… more
- PEAK Technical Staffing USA (Los Angeles, CA)
- …and supplier documents, database (Tracegains) management, and ingredient evaluation, change control support, written communications, supplier performance trend ... and regulations. Partner with Purchasing, Regulatory and R&D on raw material change control . Follow department procedure and properly document each change … more
- CPS Performance Materials Corp (Palm Bay, FL)
- …Manager. Major activities include, but are not limited to: Issue and manage change control and investigation numbers . Coordinate all required tasks associated ... relevant metrics data for annual review, board meetings, department updates SOP updates, Change Control review and coordinating approval Batch Record Control… more
