- Aequor (Libertyville, IL)
- …(ie OSIsoft PI). PURPOSE AND SCOPE OF POSITION:The Manufacturing IT Systems Quality & Compliance Specialist - Cell Therapy Manufacturing Systems ... Must have experience with IT Quality & Compliance applications and systems in a bio-tech....Responsible for Computer System Validation of local/site-based systems .Accountable for the continued compliance of IT… more
- Merck & Co. (Rahway, NJ)
- …documentation reviews. Collect, prepare and analyze data to support quality system metrics and planning. Support compliance activities such as site ... Job Description Job Description: The Rahway based Senior Specialist , Global Development Quality Operations -...audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionQuality Assurance Specialist (Hybrid) The mission of Quality Assurance is to safeguard the rights and well-being of patients; comply with ... processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies. This position reports to the Associate Director… more
- Merck & Co. (Rahway, NJ)
- …of the virtualization system and servers, capital project representation, and increasing systems that send data to an enterprise system (PI).4 years hands-on ... Software Development, Software Development Life Cycle (SDLC), Solution Architecture, System Designs, Systems Integration, TestingPreferred Skills:Job Posting End… more
- Merck & Co. (Durham, NC)
- … Quality Assurance (QA) organization, in Building 160 (B160) is seeking a Quality Specialist (P2) that will support B160's start-up and transition to ... Assurance, SFQA, and QO labs (eg, SOPs, logs, CAPAs, QNs). Support technical quality reviews of cGMP documentation for sustained compliance with QMS guidelines.… more
- Merck & Co. (Durham, NC)
- …partnership with maintenance, technical operations, operations, validation, and quality personnel.Performs routine system monitoring and troubleshooting.Performs ... Job DescriptionWe are seeking a Growth and Improvement minded Associate Specialist Automation Technician who can help drive our Strategic Operating Priorities.- The… more
- Merck & Co. (Durham, NC)
- …of the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System . Provide QA shop floor support in the execution and ... Job DescriptionPosition Description: Specialist , Quality Assurance 1st Shift -...activities requiring support include the process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of… more
- Novo Nordisk Inc. (Durham, NC)
- …industry General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS) preferred General knowledge of quality ... our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …compliance .Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Critically support investigations and reports, ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Lab Oversight Specialist I/II/III as part of the Quality team based in Raritan,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … (EDMS) while collaborating with the Engineering team to provide necessary documentation, quality system interaction, and performing a variety of highly diverse ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...prior CAD experience as they will support the CAD Specialist with CAD drawings as needed. The Engineering Area… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facility, preferably in quality assurance, manufacturing compliance , clinical quality , or cell therapyGxP Quality System knowledge, including ... in a sterile GMP environment. This role will ensure compliance within the document management system , document...tasks in a manner consistent with the safety policies, quality systems and cGMP requirementsReview and approve… more
- Merck & Co. (Durham, NC)
- …will gain a robust understanding of the aseptic processes and controls to ensure compliance and provide Quality support to site projects. The ability to work ... the Quality Sterility Assurance team, providing support to ensure compliance risk mitigation, contamination control and sterility assurance of the facilityGain… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Maintenance Specialist I (3rd shift) as part of the Facilities & Engineering team ... OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on… more
- Aequor (Oceanside, CA)
- …Change Owner responsibilities for Site Operations by managing process area and system change records including: quality actions, technology transfer changes, ... Job Title : Document Specialist Location : Oceanside, CA 92056 Duration :...be deep in Site Operations bioprocessing, document revision, the Quality / GMP change control process, and project management capabilities.… more
- Merck & Co. (Baton Rouge, LA)
- …technology systems and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, ... Job DescriptionThe Automation Senior Specialist will support startup, commissioning, and qualification on capital projects in support of our company's Animal Health… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position The Labeling Specialist supports the development of labeling activities for all...materials for product launch. This individual also supports the systems and processes by which regulatory labeling items are… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …on and manage multi-disciplined projects, with minimal supervision Understanding/application of quality systems Support of Health Authority inspections Possesses ... functional understanding of cGMPs, established manufacturing practices and procedures, and compliance with Quality regulations and guidelines Ability to… more
- Merck & Co. (Durham, NC)
- Job DescriptionSenior Specialist , Quality Systems and ComplianceOur company is expanding its global recombinant vaccine production network by investing and ... the vaccine, comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.The Quality Senior Specialist provides expertise in the… more
- Merck & Co. (Durham, NC)
- …proceed in compliance with cGMP, regulations, and our Company's Quality Management System . Supporting areas such as Design, Commissioning, Qualification ... Job DescriptionPosition Description: Senior Specialist , Quality Assurance Our Company will...project to construct the facility, process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of… more
- Merck & Co. (Durham, NC)
- …patients on time, every time, across the globe. The main function of the Associate Specialist , Quality Control is to assist in the assurance of the quality ... Job DescriptionOur Quality group ensures every single material inside our...Laboratory Practices and cGMPsAseptic techniquePerformance of environmental and water systems monitoringWorking in a team environmentPreferred Experience and SkillsStrong… more
