- 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
- Fujifilm (Warminster, PA)
- …+ Support scale-up of formulation and lyophilization processes for pilot and GMP manufacturing. + Present formulation data to cross-functional teams and ... + Able to troubleshoot equipment and experimental problems independently. + Perform advanced data analysis, use of statistical software and generate summary data … 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
- WuXi AppTec (Philadelphia, PA)
- …The **Technical Operations Specialist I** is responsible for generating and/or review manufacturing related technical documents and manage timely closure of these ... of technical transfer activities + Understands the application of GMP concepts and is able to recommend and identify...analysis, interprets, and draws conclusion of scientific and process data per good document practices + Follows compliance and… 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
- Endo International (Horsham, PA)
- …and assist in completing process deviation investigations/unplanned events. Author, review , and approve cGMP documentation - manufacturing process and equipment ... programs. Utilize statistical control software to analyze and trend process and facility data and results. + Support the Horsham site validation program - Author/… 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 (Merion, PA)
- …(AspenTech) and DeltaV systems within the biopharmaceutical environment. Write, review , and execute validation protocols including Installation Qualification (IQ), ... (OQ), and Performance Qualification (PQ) for systems in line with GMP requirements. Prepare and maintain comprehensive validation documentation, risk assessments,… 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
- Catalent Pharma Solutions (Philadelphia, PA)
- …global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. ... in accordance to company policies, procedures and regulations contained in company GMP 's, safety standards, and SOP's. Demonstrates competency in plant safety and… 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
