- Eisai, Inc (Exton, PA)
- …into the production suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with ... R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at...close-out reports for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of… more
- Eurofins (King Of Prussia, PA)
- …Testing. + GMP review of Qualification and Media Release testing. + GMP review of facility cleaning data and in-processing testing, including but not ... stocks in Europe over the past 20 years. + Water Systems + GMP review of microbiological testing of the facility and/or laboratory water purification system… more
- Charles River Laboratories (Newark, DE)
- …**Job Summary** Charles River Labs is seeking an experienced professional for a Data Review Scientist- Sequencing ,focused in Next Gen and Sanger Sequencing, ... position located in Newark, Delaware. The Data Review Scientist- Sequencing will be responsible...generate identification reports. Ensure that all regulatory requirements and GMP compliance are adhered to. Essential Duties and Responsibilities… more
- Merck (West Point, PA)
- …Business, Business Process Improvements, Corrective Action Management, Database Administration, Data Management, Deviation Investigations, GMP Compliance, Good ... systems to be compliant and inspection ready state by performing periodic review , alarm management, system upgrade and SOP updates. + Participate and contribute… more
- Teva Pharmaceuticals (West Chester, PA)
- …your main responsibilities will be scheduling and supporting microbiological laboratory testing, data review , analysis of endotoxin and bioburden samples, and ... clinical development and commercial production for biological products manufactured in a GMP production facility. **How you'll spend your day** Position Summary: *… more
- West Pharmaceutical Services (Radnor, PA)
- …integrity (CCI) assessments in compliance with Good Manufacturing Practice ( GMP ) regulations. This role involves method execution, documentation, and collaboration ... strong analytical skills, and a thorough hands-on understanding of GMP requirements. **Essential Duties and Responsibilities** + Conduct performance and… more
- Merck (West Point, PA)
- …filings. + Design, plan, and execute laboratory experiments to generate high quality data . Perform data analysis and ensure results are reported clearly and ... with research and commercial teams to deliver process documentation packages, review batch records, support technology transfer activities, and provide investigation… more
- Merck (West Point, PA)
- …Biomedical Engineering, Bioprocessing, Business, Cell Cultures, Communication, Cryopreservation, Data Analysis, Decision Making, Detail-Oriented, GMP Compliance, ... and regulatory filing activities to ensure a smooth and clear path to successful GMP operations and BLA filings for the company's pipeline. + Leads and/or supports… more
- Merck (Wilmington, DE)
- …Quality Risk Management Lead will: 1. In-depth knowledge of US and European GMP guidelines 2. ICH and other international regulatory requirements, as applicable to ... program, including integration into the quality management system 12. Accountable for review of site level QRM activities 13. Accountable for on-time schedule-based… more
- Merck (West Point, PA)
- …Management, Clinical Testing, Clinical Trial Management, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Good Manufacturing Practices ( GMP ), ... supply chain deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders. + Works directly in the… more
- Merck (West Point, PA)
- …chain deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders. + Responsible and accountable ... both technical & business risks, & influence portfolio decisions with facts and data + Demonstrates ability to balance strategy with ability for tactical execution… more
- Catalent Pharma Solutions (Malvern, PA)
- …oriented individual with ability to articulate, receive, disseminate and analyze data . The Quality Specialist, Quality Management Systems is responsible for ... products in accordance with quality specifications, government, company and GMP standards **This is a full-time role position:** **Monday-Friday 8:00am-5:00pm.… more
- Insight Global (Malvern, PA)
- …for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 -- 10 other ... drug product/drug substance samples -Perform peer reviews and approvals of laboratory data -Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and… more
- J&J Family of Companies (Malvern, PA)
- …Cell culture and cryopreservation of cells using aseptic techniques under GMP [1]Compliant conditions. * Execute all activities per established procedures and ... * Collaborate cross-functionally to represent Cell Banking department. * Author, review , and approve technical documents, SOPs, and batch records. * Successfully… more
- Kelly Services (West Point, PA)
- …of computerized analytical systems prior to validation. + Participate in various data integrity and lab modernization activities as required. + Will possess direct ... (vaccine or large molecule focus). + Will have the ability to thoroughly review and scrutinize validation requirements through the life cycle of the system.… more
- ThermoFisher Scientific (Collegeville, PA)
- …validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against ... laboratory activities, including sample analysis. + Identify and effectively communicate analytical data . + Review analytical test results. + The individual… more
- Turner & Townsend (West Point, PA)
- …**Responsibilities:** + Manage Cost / Change Control, including change order review , negotiation, recommendations, and delay analysis. + Track and review ... Contractor. + Produce monthly reports for management. + Providing review reports. + Produce earned value reports. + ...cost tracking reports. + Reconcile GC actual costs with GMP / Schedule of Values. + Contract Administration (retention, T&Cs,… more
- J&J Family of Companies (Malvern, PA)
- …with Method Development, Assay Automation, Integrations, Orchestration, Information Technology, Data Science, and Operations to increase sample testing volume while ... end-users to independently execute automated workflows + Partnering with Information Technology and Data Science teams to automate data flows to ensure data… more
- dsm-firmenich (Exton, PA)
- … data analysis, statistical process control (SPC), CAPA, KPI's, Review , and Trending. Responsible for product-related root cause analysis, process mapping ... and recommend disposition and corrective actions + Create suitable data analysis tables and report findings based on statistical...in the transition of development products and projects + Review new product designs (internal and external) and make… more
- Merck (West Point, PA)
- …Manufacturing Division is: + Accountable to the Development Commercialization Review Committee (DCRC) for delivering a fully integrated stage-appropriate development ... serve. + **_Problem Solving and Innovative Thinking_** **:** Gathers and analyzes data and effectively responds to new or complex situations, developing creative and… more
