- Merck & Co. (Rahway, NJ)
- …on time, every time, across the globe.Summary, Focus and PurposeThe Director of GMP Compliance will report to the head of the Global Quality Compliance Support ... operating units and requires extensive partnership with manufacturing sites and global GMP SMEs.Key FunctionsServe as a subject matter expert for good manufacturing… more
- Merck & Co. (Rahway, NJ)
- …Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of oral solid dosage, sterile, and specialty dosage forms.- ... providing feedback on product and process development.These roles require adherence to GMP procedures, strong attention to detail in completing GMP … more
- Merck & Co. (Rahway, NJ)
- …and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development ... providing feedback on product and process development.These roles require adherence to GMP procedures, strong attention to detail in completing GMP … more
- Aequor (South San Francisco, CA)
- …and packaging materials for further manufacturing o Manage the compilation of a GMP - and customs-compliant goods receipt dossier for the QA-release of drug products ... and packaging materials o Request and continuously GMP and non- GMP -batch data of drug products and packaging materials in SAP o Ensure the on time QA-release or… more
- Aequor (Aliquippa, PA)
- …The candidate will physically work on-site at Langham Logistics, a third-party GMP -compliant warehouse in Pennsylvania. Expected hours: 8:00 AM to 5:00 PM, ... 5&plus years of QA experience specifically involving raw materials in a GMP -regulated environment such as pharmaceutical, biotech, or other life sciences industries.… more
- Merck & Co. (Durham, NC)
- …activities are completed in accordance with established safety, GMP , and calibration/maintenance proceduresWork with the Operations, Technology, Automation, ... management skillsWorking knowledge of regulatory requirements in accordance with GMP manufacturing operationsGood oral and written communication skillsExperience with… more
- Merck & Co. (Durham, NC)
- …activities are completed in accordance with established safety, GMP , and calibration/maintenance procedures.Work with the Operations, Technology, Automation, ... management skillsWorking knowledge of regulatory requirements in accordance with GMP manufacturing operationsGood oral and written communication skillsQualify and… more
- Merck & Co. (Durham, NC)
- …Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations. Effective communication both written and oral Effective ... Electrical or Instrumentation.Experience working in a clean room or GMP /regulated manufacturing environment.Installation, operation, maintenance and/or troubleshooting experience with… more
- Merck & Co. (Durham, NC)
- …Electrical, or Instrumentation.Experience working in a clean room or GMP -regulated manufacturing environment.Familiarity with automated process equipment in the ... biopharmaceutical field.Knowledge of GMP -compliant calibration and/or maintenance database systems.Experience with SAP, DeltaV, and ProCal systems.Physical… more
- Merck & Co. (Rahway, NJ)
- …drug product design from the bench top to the Good Manufacturing Practice ( GMP ) manufacturing facilities, our Scientists use cutting edge science to transform drug ... drug products . - Capability to lead manufacturing operations in non- GMP and GMP environments. - Executes routine experiments and data interpretation with… more
- Merck & Co. (Durham, NC)
- …and complex problems in a fast-paced environment. Aseptic manufacturing and GMP manufacturing experience. Strong planning, scheduling, and time management skills ... Working knowledge of regulatory requirements in accordance with GMP manufacturing operations Strong oral and written communication skills Strong problem solving and… more
- Merck & Co. (Rahway, NJ)
- …method development, validation, and method transfer, as well as provide technical and GMP support during CCIT by internal and external sites and be familiar with ... for vials, medical device release testing in a timely manner following GMP procedures.Document the execution, procedure, results, and conclusions of experiments in a… more
- Merck & Co. (Durham, NC)
- …data collection techniques, and troubleshooting in compliance with SDLC, GMP , safety, and environmental regulations.- Actively support, participate and embrace ... version 12+ required including Batch control Minimum of 4 years of GMP Computer validation and systems life-cycle development methodology experience required. Proven… more
- Merck & Co. (Durham, NC)
- …State and Local code requirements for quality, good manufacturing practices ( GMP ), equal employment opportunity, finances, labor, employee, environment, and safety, ... degree and two (2) years of experience in a direct GMP , biotechnology, and manufacturing setting.Required Experience and SkillsAbility to develop and… more
- BioAgilytix (Durham, NC)
- …for prompt identification and notification of deviationsPerform assays according to GMP guidelinesFollow GMP guidelines for validation of assaysDevelop and ... cell-based assays in qPCR and Flow Cytometry. It is a plus to have GMP industry experience. Must work effectively within team to meet objectives under time… more
- Merck & Co. (Durham, NC)
- …degree and at least One (1) year of experience in a direct GMP , biotechnology, manufacturing setting.Required Experience and Skills: Experience working in a GMP ... Environmental Health and Safety (EHS) Management, Equipment Set Up, GMP Compliance, Leadership, Lean Manufacturing Tools, Management Process, Operations Support,… more
- Merck & Co. (Durham, NC)
- …Equipment Maintenance, Equipment Set Up, Equipment Troubleshooting, Fabrication Processes, GMP Environments, GMP Operations, Good Manufacturing Practices ( ... GMP ), In-Process Control (IPC), Life Science, Maintenance Processes, Manufacturing Processes, Problem Resolution, Process Troubleshooting, Production Scheduling, Recordkeeping, Standard Operating Procedure (SOP) Management, Sterile Manufacturing,… more
- Merck & Co. (Durham, NC)
- …and Local code requirements for quality, good manufacturing practices ( GMP ), equal employment opportunity, finances, labor, employee, environment and safetyTactical ... degree and two (2) years of experience in a direct GMP , biotechnology, manufacturing setting.Required Experience and Skills:Demonstrated ability to lead a… more
- Merck & Co. (Rahway, NJ)
- …compliance requirements are achieved, eg - Good Manufacturing Practice ( GMP ), safety, and environmental.Supports a Target Zero Safety Culture.Documents Maintenance ... Material(s):n/aRequired Skills:Application Maintenance, Environment Health and Safety, Equipment Maintenance, GMP Compliance, Good Manufacturing Practices ( GMP ), Maintenance… more
- Merck & Co. (Durham, NC)
- …calibration, assigned capital project work, and support Good Manufacturing Practice ( GMP ) operations for all facility shutdownsCoordinates with Site Engineering and ... (BAS) and control systems in a Good Manufacturing Practices ( GMP )environment.Must be aware of requirement specifications from a qualification perspective (IC/OC,… more
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