- Merck & Co. (Millsboro, DE)
- …federal and state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards, and emissions ... humane animal care and usage. Maintain company Federal (DEA) and State controlled substances registrations and be responsible for controlled substance use,… more
- Aequor (Thousand Oaks, CA)
- …and Risk Management objectives, and initiating and/or implementing changes in controlled documents. Must learn and comply with safety guidelines, and cGMPs/CFRs ... processes and methodologies 7. Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact. 8. Support… more
- Aequor (Bothell, WA)
- …practices including cycle counting, and rejected/expired material disposition Understanding controlled temperature, humidity, and pest control monitoring for cGMP ... in a fast-paced environment Responsibilities: Working Conditions: Lab environment of Controlled Non-Classified and ISO8 areas Physical Requirements: Ability to lift… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …empowering business users to create automation solutions within a controlled governance modelIntelligent Process Automation & RPA Implementation:Lead the deployment ... automationCollaborate with security, infra & data teams to ensure controlled , scalable, and compliant citizen development practicesBudget Management, Change… more
- Merck & Co. (Durham, NC)
- …and products needed to support manufacturing. - Operates various computer- controlled process support/process equipment Assists in troubleshooting of equipment. - ... Performs housekeeping in all work areas. Executes facility sanitization and decontamination according to approved procedures. - Completes in-process testing and inspections supporting the vaccine manufacturing, validation, and development processes as required… more
- Repligen (Clifton Park, NY)
- …abilities. Experience working in a classified cleanroom, and knowledge of GMP/ISO/document- controlled processes would be beneficial. Attention to detail, and the ... ability to work in a team environment are essential. ResponsibilitiesLead and supervise all site personnel involved, collaborating with headquarters functions for harmonization for matrixed roles.Lead all operations at the site, including Planning,… more
- Aequor (Athens, GA)
- …responsibility for programs such as biosecurity, hazardous shipping, supply systems, controlled drug inventories, and other site or multi-site needs at direction ... of Group Leader. May serve on cross-site or whole-company committees or workgroups, such as as the Biosafety Committee, Environmental Health and Safety (EHSS), etc. May serve as site representative for specific functions such as Biosafety Officer, Chemical… more
- Merck & Co. (Rahway, NJ)
- …technologies, including: continuous manufacturing, t hree d imensional (3D) printing, controlled release , and/or oral delivery of large molecules. - Experience ... with process modeling, simulation , and automation integration in the pharmaceutical and/or industrial manufacturing sector. - Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies. -… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Pharmaceuticals or related industry is preferredExperience working in a controlled , cleanroom environment under aseptic conditions is preferredExperience in HVAC ... and cleanroom maintenance is preferredExperience with CMMS or similar maintenance management system is requiredProficiency in English (verbal and written) and strong communication skillscGMP manufacturingMaintenance, facilities and utilitiesComputerized… more
- Aequor (Newbury Park, CA)
- …they are used in the process and how they should be controlled . Facilitate specification development meetings and generate meeting minutes/action items to partners ... to ensure completion of tasks. Other responsibilities include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner. Skills: Degree in Life Science or… more
- AUROBINDO (Durham, NC)
- …broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Aurobindo has business operations in more than 125 ... countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages. Aurobindo markets over 80% of the top 100 most prescribed… more
- Twist BioScience (South San Francisco, CA)
- …similar programsTypical Working Conditions are:Team based laboratory environment.Working in controlled laboratory environmentMust be able to stand for long periods ... of time while performing duties.Must be able to work safely with chemicals and hazardous materials.Must be able to lift up to 20 lbs.Must be able to work outside of regular work hours/ work a flexible shift as neededAbout Twist BioscienceTwist Bioscience… more
- BioAgilytix (Durham, NC)
- …locked data).Harmonize Multi-Site, Multi-Assay Data: Standardize fields, units, and controlled vocabularies (eg, CDISC SDTM/SEND) to present a single, consistent ... dataset to sponsors.Automate Delivery Workflows: Leverage RPA, scripted edit checks, and audit-trail capture to shrink cycle times and reduce defects.Enable Self-Service Access: Provide dashboards, secure APIs, or portals that allow sponsors real-time… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from the GSOP Committee)Proactively manage required periodic review for controlled proceduresEnsure global and cross-functional consistency of process documentation ... to the extent possible by coordinating reviews and updates with relevant process owners / SMEsMonitor key GRA process performance / adherence / metrics to proactively address operational risksServe as a regional Process expert regarding maintaining a compliant… more
- Eisai, Inc (NJ)
- …with TMF leadership and other relevant stakeholders on SOP, associated controlled documents and applicable eTMF system trainings.Essential Functions Manage and drive ... to completion required daily eTMF system related activitiesEnsure eTMF system and associated process align with ICH-GCP, regulatory and Eisai SOPsOversight of eTMF vendor(s) and related TMF setup and maintenance processes, eTMF user support and… more
- Pall (Miami, FL)
- …to ensure changes are adopted with minimum disruption to implemented, controlled , and sustained throughout the business and meet PO requirements.Proactively Engage ... with R&D/Design engineering and Product planning teams to ensure new product/material design complies with regulatory requirements for intended markets.EDUCATION/PRIOR EXPERIENCE REQUIREMENTS BS/BA REQUIRED with a preferred relevant engineering major, Quality… more
- Raytheon (Mckinney, TX)
- …and test integrity.Collaborate with Digital Technologies to integrate TE to controlled networks or enterprises.Collaborate with Cybersecurity to ensure TE compliance ... (using tools such as Nessus, Splunk, Ivanti, and locally procured softwareCollaborate with engineering to ensure changes do not affect the availability or test integrity on the TESupport any and all reviews required prior for implementation of any changes to… more
- Raytheon (Andover, MA)
- …learn production operations and the manufacturing discipline in a controlled environment. They develop manufacturing engineering skills, an understanding of ... manufacturing (cost, quality, safety and schedule), and Raytheon systems and tools. MEs build technical depth in manufacturing processes and are accountable for improvement and optimization.Primary responsibilities include developing the comprehensive… more
- Raytheon (Mckinney, TX)
- …problems. Factory production execution support includes developing and implementing well- controlled processes using data-driven methods such as Statistical Process ... Control (SPC) and Design of Experiments (DOE) and writing shop process documentation. Developing and executing new product builds typically with automated equipment, often requiring creative solutions for next-generation product designs.Ensuring processes… more
- Veterans Affairs, Veterans Health Administration (Hampton, VA)
- …in the areas of pharmacology, therapeutics, drug interactions, IV additives, controlled substance regulations, and various drug distribution systems. The incumbent ... 1108.01. Prepares all Omnicell inpatient and outpatient order requests for controlled substances and maintains necessary records of activity. Prepares order for… more
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