- Merck & Co. (Durham, NC)
- …seeking a Growth and Improvement minded Quality Control Laboratory Associate Specialist that can help drive our Strategic Operating Priorities.Invent-- Pursue the ... product and support laboratory testing for vaccines.The Quality Control Laboratory Associate Specialist participates on a team of analysts in the method transfer,… more
- Merck & Co. (Durham, NC)
- …Practices process demonstration (IQ/OQ/PQ)Sustaining the validated state through change management and continuing validation studiesStrong technical ... to these programs.Author, review, and/or edit validation documents to support regulatory filingsSupport Change Control documentation for complex process,… more
- Merck & Co. (Durham, NC)
- …ingredient, finished product, and laboratory testing for the BCG vaccine.The Associate Specialist participates in a team of analysts in the development, validation, ... validation, and GMP laboratory readiness.- The Quality Operations Laboratory Associate Specialist performs laboratory testing on a variety of product samples and… more
- Merck & Co. (Rahway, NJ)
- …expertise in SLC methodology (eg, V-model, waterfall, agile, spiral) including change management .Extensive experience providing oversight for adherence to ... corrective action/preventive action, procedural controls, auditing and Quality Risk Management .As required, participate in Regulatory Agency inspection… more
- Merck & Co. (Durham, NC)
- …development and management - Sustaining the validated state through change management and continuing validation studiesExperience with on-the-floor cGMP ... seeking a Growth and Improvement minded Manufacturing Vaccines Technical Operations Specialist that can help drive our Strategic Operating Priorities.Invent - Pursue… more
- Merck & Co. (Durham, NC)
- Job DescriptionDurham's Technical Services Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills to ... Fermentation, Alum, Clean Utilities, and Facilities area. The position also involves management of technical projects to augment the HPV Technical Operations and… more
- Aequor (Bothell, WA)
- …is preferred. Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, Management Monitoring and Self Inspection ... cross-functional experience, strong interpersonal skills *Job Description: The Quality Assurance Specialist position plays a key role in supporting the cGMP quality… more
- Aequor (Seattle, WA)
- …project management skills. Experience interacting with FDA or other regulatory agencies strongly preferred. Strong knowledge of cGMPs and domestic regulatory ... cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist , Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively support, participate and embrace an empowered team culture… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... leading centers for oligonucleotide innovation and manufacturing. Together, we are driving change . Are you ready to make a difference? The Position The primary… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …members. Strong analytical, problem solving and critical thinking skills. Project management . Change management . Operational excellence, continuous ... instrumentation, automation PLCs, VFDs and electrical practices. Computerized maintenance management systems (CMMS). EHS and regulatory standards (eg… more
- Arthrex (Naples, FL)
- …Treat Their Patients Better (TM) . We are currently seeking a motivated International Regulatory Affairs Specialist I to join our collaborative team at our ... Free Sale, and Certificates of Exportability. Evaluate the risk of proposed regulatory strategies and offer solutions, as applicable. Partner with in-country … more
- Spectraforce Technologies Inc (Bridgewater, NJ)
- …cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding ... Job title: CMC Regulatory Technical Writer II Location: Bridgewater, NJ, Hybrid...regulatory submissions for both development and post-approval dossiers, change controls and technical reports. He/she coordinates directly with… more
- Computer World Services (CWS)Corporation (Washington, DC)
- …Key Tasks and Responsibilities The OFR is seeking an experienced knowledge management specialist to Assist in the design, development, and implementation ... of the activities of the OFR available to financial regulatory agencies; and assisting such member agencies in determining...experience. Comprehend and recognize key barriers to KM behavioral change and develop effective change management… more
- DivIHN Integration Inc (Lake Forest, IL)
- …day to day activities for change control. Provides consultation/advice to regulatory specialist for change control and product development. Provides ... one of our Talent Specialists Rashi at ### Title: Regulatory Affairs Specialist II - 5 Openings...description will be reviewed periodically and is subject to change by management . RESPONSIBILITIES: Responsible for technical… more
- DivIHN Integration Inc (Scarborough, ME)
- …day to day activities for change control. Provides consultation/advice to regulatory specialist for change control and product development. Provides ... Talent Specialist Rashi | 630 8471027 Title: Regulatory Specialist II Location: Scarborough, ME Duration:...description will be reviewed periodically and is subject to change by management . Exempt/Non Exempt: Non Exempt… more
- Merck & Co. (Durham, NC)
- …or metrology.Project Management experienceStrong planning, scheduling, and time management skillsFamiliarity of regulatory requirements in accordance with ... Job DescriptionThe Associate Specialist , Calibration Engineer is a member of the...Center, Vaccine Bulk and Manufacturing Facilities, Quality Labs, Material Management Storage Facility (MMSF) and FLASH project. At times,… more
- DivIHN Integration Inc (Green Oaks, IL)
- …contact one of our Talent Specialists Meghna at ### Rashi at ### Title: Regulatory Affairs Specialist Location: Abbott Park, IL Duration: 7 Months Description ... role As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support...execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration… more
- DivIHN Integration Inc (Santa Clara, CA)
- …day to day activities for change control. Provides consultation/advice to regulatory specialist for change control and product development. Provides ... Talent Specialists Rashi at ### Divya at ### Title: Regulatory Specialist II Location: Santa Clara, CA...on control of product release; experience working with electronic change management /document control systems. Skills: Knowledge of… more
- DivIHN Integration Inc (North Chicago, IL)
- …contact one of our Talent Specialists Meghna at ### Rashi at ### Title: Specialist Regulatory Affairs Duration: 7 Months Location: Abbott Park, IL/ Columbu, OH ... expedite approval of pending registration. Participates/ Awareness on project plans, regulatory submission strategy, any risks management . Advises project teams… more
