- KPMG (Houston, TX)
- …Sciences Solutions for our Consulting (https://advisory.kpmg.us/) practice. Responsibilities: + Lead Quality Systems related and Digital Transformation projects ... degree from an accredited college/university preferred + Experience configuring and implementing TrackWise Digital - Quality Management System for the Life… more
- Capgemini (Richmond, VA)
- …MES implementation experience + Hands on technical experience in implementing MES systems like TrakSYS or any other MES system + Proven experience with ... **Job Title: MES Technical Lead ** **Job Location: Richmond, VA...cross system Integration LIMS/ Trackwise /JDA BY/PCS + Excellent communication and client management skills… more
- Pfizer (Sanford, NC)
- …will play a critical role in Quality Operations. The Manufacturing Quality Assurance (MQA) Technical Lead provides leadership to a team of Associates who are ... activities related to any of the modalities manufactured at Sanford. The MQA Technical lead will evaluate and review Pfizer's clinical and commercial batches… more
- CGI Technologies and Solutions, Inc. (Cambridge, MA)
- …requirements and processes to integrate and optimize Veeva QMS and Trackwise systems within our operations. * Lead the requirement gathering sessions and ... data analysis and migration activities, ensuring data integrity and system efficiency between Veeva QMS and Trackwise ....in Pharma QMS and specific to Veeva QMS and Trackwise . * Strong technical skills, including experience… more
- ThermoFisher Scientific (Mount Prospect, IL)
- …analysis tools (eg, 6M, Fishbone, TapRooT) and general problem-solving techniques. + Lead , initiate, and assist with the completion of immediate corrections and CAPA ... site champion. + Engage in and adhere to departmental systems to maintain a smooth and efficient workflow, including...industry. + Minimum of 3 years of experience in technical or scientific writing principles. + Demonstrable knowledge of… more
- Lilly (Concord, NC)
- …and provide support to resolve equipment alarms and other issues in quality systems such as Trackwise and MES. + Maintain open communications between ... work independently with minimal supervision + Proficiency with computer systems including Trackwise , MES, Microsoft Programs +...Systems (MES) or electronic batch records + Previous technical writing experience + Technical aptitude and… more
- Lilly (Concord, NC)
- …and provide support to resolve equipment alarms and other issues in quality systems such as Trackwise and MES. + Maintain open communications between ... Ability to work independently with minimal supervision. + Proficiency with computer systems including Trackwise , MES, Microsoft Programs. + Responsible for… more
- Fujifilm (Research Triangle Park, NC)
- …audit actions, deviations, lab investigations, method revisions, and other related Quality System activities + Takes lead in problem solving and troubleshooting, ... & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral...products that transform the lives of patients. The **QC Lead Associate II** will support a broad range of… more
- CGI Technologies and Solutions, Inc. (Cambridge, MA)
- …a deep understanding of both the business and IT aspects of Quality Management Systems (QMS), particularly in migrating data from TrackWise to Veeva QMS. The ... SME will play a critical role in responding to RFPs with technical approaches, crafting solution proposals, and leading significant implementation projects. Role… more
- Abbott (Waukegan, IL)
- …with applicable **Corporate and Divisional Policies and procedures** . + **Serve as technical expert** or lead project technical resources to develop, ... **The Opportunity:** + Responsible for delivery of projects with multiple systems within the Quality, Regulatory and Engineering domains. + Provides in-depth… more
- GE HealthCare (FL)
- …to Field Engineers (FEs), Client Service Technicians (CSTs), and Customers experiencing system performance issues. This position is the technical resource for ... period of 5 years before consideration. + Demonstrated ability to handle/resolve difficult technical issues with advanced knowledge in applicable systems + Legal… more
- Lilly (Durham, NC)
- …serves as a power user and data steward for the Complaint Management TrackWise / Veeva system and performs complaint investigations for RTP manufacturing, ... cGMP documents, and maintaining regulatory compliance. **Key Objectives / Deliverables:** + Technical knowledge of complaint handling and/or quality systems +… more
- Amicus Therapeutics (Princeton, NJ)
- …health authority inspections. Support any activities for record retention, archive and system maintenance related to the electronic management systems employed. ... for the document management system and/or training system in use. Manage or lead projects...and trending systems . 5. Previous experience in systems such as Master Control, TrackWise , Documentum,… more
- Lilly (Lebanon, IN)
- …support the execution of the production plan for the site. + Utility Operator Systems : Water Systems , Boilers, Nitrogen System , Chillers, Instrument Air, ... maintained in accordance with local and corporate regulatory requirements. + Enter Trackwise events, participate in and lead CAPA investigations + Troubleshoot… more
- Charles River Laboratories (Memphis, TN)
- …and experience writing and reviewing investigations within a Quality Management System ( TrackWise , preferred) + Experience must include proven knowledge ... in Memphis, TN** The Site Data Integrity (DI) Program Lead is responsible for ensuring the site operates under...in a regulated industry, or 5 years with related technical knowledge including data integrity related to quality control,… more
- Catalent Pharma Solutions (San Diego, CA)
- …systems is preferred - JD Edwards 9.2, DSI, GSA, SupplyFlex, ComplianceWire, TrackWise , EDMS (Electronic Document Management System ), etc. + Excellent written ... **Associate Project Lead , Pre-production** **Position Summary:** Catalent is a global,...output material IDs and Lot numbers within current inventory system + Attend project kick-off meetings. Client interaction and… more
- Astellas Pharma (Westborough, MA)
- …systems including Change Control administration, Calibration / Validation review, Trackwise system champion and workflow development, inspection management ... **Sr. Quality Systems Engineer** Do you want to be part...compliance deliverables. **Essential Job Responsibilities:** + Serves as a lead with the management and administration of the GMP… more
- Catalent Pharma Solutions (Madison, WI)
- Position offering $2,000 net sign on bonus **Position Summary** **Associate Lead I - Biomanufacturing, Technical Writing** Catalent is a global, high-growth, ... manufacturing in accordance with regulatory, site, and client requirements. The Associate Lead I - Biomanufacturing, Technical Writing under minimal supervision,… more
- AbbVie (Branchburg, NJ)
- …skills (Power Query, pivot tables, complex formulas, etc.) requiere. + Familiarity with business systems such as SAP and Global TrackWise is preferred. + Lean, ... Job Description We are looking for a skilled Quality Systems Analytics Specialist to join our team at the...Branchburg site. This position offers a unique opportunity to lead and develop a data-driven culture within our quality… more
- Lilly (Lebanon, IN)
- …maintained in accordance with local and corporate regulatory requirements. + Enter Trackwise events, participate in and lead CAPA investigations + Troubleshoot ... a successful startup into GMP manufacturing operations._ **Position Brand Description:** The Lead Operator for Tank Farm and Solvent Recovery Operations is directly… more