- Repligen (Hopkinton, IA)
- …Quality Management System. This role is responsible for inspecting, auditing and reporting on in- process and final inspection of single use assembly parts at the ... customer quality standards.ResponsibilitiesThe QC Inspector I will be responsible for:Conduct inspection of single use assembly designs of customers and approves or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Procedures: Reviews, approves, provides input on and authors SOPS, SOIs, and process guides. Participates in inspection preparation activities and internal and ... external audits and audits CAPA preparation.Case Processing Training: Identifies case processing and related CRO/vendor training needs and reviews case processing project specific training materials. Manages and coaches the PV Vendor Training Coordinator.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs ... (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi...in this role will also be responsible for overseeing inspection readiness and supporting internal audits and Health Authority… more
- Insmed Incorporated (San Diego, CA)
- …Medium Workplaces™ lists.OverviewWe are seeking a highly motivated expert in purification process development of viral vector gene therapy products. In this role you ... for performing experiments ranging from purification development and optimization, process characterization and clinical manufacturing investigation support. As part… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …The Position This role will be part of our manufacturing downstream purification process support team, dedicated to one of our manufacturing suites. Responsible for ... instrumentation and equipment start-ups from the laboratory through manufacturing scale. The Process Engineer I will work alongside Process Associates and … more
- Novo Nordisk Inc. (Durham, NC)
- …and help us make what matters. The Position Seeking an experienced to Sr level Process Engineer to support the bulk process tableting line. This role will ... business & regulatory requirements through the following activities: People Focus, Process Focus, Equipment Focus & Standards "Gatekeeper". Relationships Reports to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary: The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that ... regional management teams plans, will support, conducts and reports internal systems and process audits across the organization as appropriate for the area of GxP… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process and equipment troubleshooting to support deviations, corrective actions ... in design and hazard reviews of plant expansions or process changes and serving as the technical point of...activities such as: reading, writing, and analyzing; and visual inspection . The working environment includes a variety of physical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include interactions with NNI vendors involved in the NNI pharmacovigilance process and routine networking through membership in industry association(s). Manage ... resources (eg training program, FAQs) to enable compliance with QMS process requirements across NNI and global as applicable Proactively identifies risks/quality… more
- Merck & Co. (Durham, NC)
- …Operations areas (sterile supply, weigh/dispense, media, stabilizer/prep, thaw/pool, filling, capping/ inspection , clean utilities etc.) located in aseptic and clean ... related equipment (eg Autoclaves, Fillers, Lyophilizers, Cappers and Automated Inspection MachinesThe ability to satisfactorily perform all types of industrial… more
- Merck & Co. (Durham, NC)
- …Operations areas (sterile supply, weigh/dispense, media, stabilizer/prep, thaw/pool, filling, capping/ inspection , clean utilities etc.) located in aseptic and clean ... related equipment (eg Autoclaves, Fillers, Lyophilizers, Cappers and Automated Inspection MachinesThe ability to satisfactorily perform all types of industrial… more
- Repligen (Clifton Park, NY)
- …for area cleanlinessread and understand quality and inspection documentsread/understand molding drawingsbasic math competencyunderstanding of measuring ... supplies or manufacturing experience is a huge plus.Quality control or inspection experience is highly desirablePrevious experience working in a Cleanroom… more
- Merck & Co. (Durham, NC)
- …of both drug substance and drug product, including product inspection , warehouse, utilities, and quality control laboratories.The Specialist, Operations will ... to the manufacturing team and support for the facilityLeading routine process support, projects, and improvement activitiesServing as subject matter expert on… more
- Merck & Co. (Rahway, NJ)
- …with assembly equipment integrated processes such as ultrasonic welding and vision inspection systems.Author technical content of assembly process FMEAs to ... Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops… more
- Eisai, Inc (Nutley, NJ)
- …North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is ... audits of study sites, clinical vendors, clinical documents, and internal process audits Facilitate Sponsor health authority inspections of global clinical… more
- Merck & Co. (Rahway, NJ)
- …submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning, etc.The incumbent will be responsible for continuous improvement of ... our electronic submission process and providing tools and templates to support delivery...Conversions.Demonstrated success in the assurance of deliverable quality and process compliance.Excels in technical writing, able to convert complex… more
- Aequor (East Syracuse, NY)
- …used in the testing and characterization of raw materials, excipients, in- process , drug substance, and drug product samples including HPLC/UPLC methods and ... is preferred. Working knowledge and experience in the biopharmaceutical development process , GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial… more
- Merck & Co. (Rahway, NJ)
- …and external quality audits and maintain laboratory state of permanent inspection readiness Author or contribute to Standard Operating Procedures (SOP) ... company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …Actual starting pay depends on the experience and skills considered during the offer process . Relocation expenses may be considered during the offer process as ... planning and development function as well as codes and building inspection . This employee should possess excellent communication, organizational, and public relation… more
- Repligen (Clifton Park, NY)
- …raw materialsOperation of extruders and associated production equipmentIn- process dimensional measurements using precision instrumentsResponsible for following ... SOPs and safety proceduresResponsible for area cleanliness and inspection readinessAbility to lift 50lbs, must speak English and have 20/20 or corrected 20/20… more
