- Repligen (Hopkinton, IA)
- …role is responsible for inspecting, auditing and reporting on in-process and final inspection of single use assembly parts at the Hopkinton, MA production facility, ... customer quality standards.ResponsibilitiesThe QC Inspector I will be responsible for:Conduct inspection of single use assembly designs of customers and approves or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …corrective action(s)/preventative action(s) (CAPA) in connection with audit and/or inspection responses, and ensure proper implementation across various areas of ... Standard Operating Procedures (SOPs) Advanced knowledge and participation on internal audit/ inspection readiness (ie FDA PADE inspection ) Excellent interpersonal… 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)
- …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
- Aequor (Davie, FL)
- …as computer work, preparing and analyzing data, extensive reading, and visual inspection involving small defects, small parts and/or operation of machines (including ... inspection ), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes. Operate motor vehicles or heavy equipment. WORKING… more
- Aequor (Thousand Oaks, CA)
- …the ability to lift 50&plus pounds and pass a vision assessment for inspection work. Candidates must be comfortable working with raw materials and components, though ... overtime. Under general supervision, this position is responsible for sampling and inspection of raw materials and components and for performing Quality review of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The individual in this role will also be responsible for overseeing inspection readiness and supporting internal audits and Health Authority (HA) inspections. For ... GRA processes and ways of workingDrive activities required for GRA to be inspection ready, and support addressing any observations or findings that may result from… more
- AUROBINDO (Durham, NC)
- …that the scale is providing accurate information.Check and perform daily inspection of electric forklifts and electric hand trucks.Provide assistance in movement ... and dispensing team.Maintain record keeping of all material movement within the warehouse. Inspection and loading of finished products shipments.To drive the truck to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functions, internal and external stakeholders to execute audits effectively.Support inspection readiness by preparing clinical teams, Clinical Safety and ... for key Health Authority pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up activities post inspection … more
- Aequor (Cincinnati, OH)
- …scientific glassware in dishwasher according to written procedures Handwashing glassware Inspection of glassware following cleaning to ensure it is safe ready ... Change out pipet soakers on a weekly basis Receive incoming samples Perform inspection of house cleaning checklist weekly Monitor and implement safety procedures as… more
- Repligen (Clifton Park, NY)
- …molding drawings Basic math competency Understanding of measuring instruments Inspection and cleaning of partsQualificationsPrevious experience in production and ... machine operation is preferredAbility to life 50 lbs,must speak English and have 20/20 or corrected 20/20 visionAbility to stand for long period of timeOvertime opportunity is availableHigh School Diploma or Equivalent requiredAll applicants subject to a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and inspections and execute against these metrics consistently. Provide inspection management support regarding compliance concerns identified during internal ... systems audits, remediations implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory guidelinesEnsure up to date audit CAPA information in the eQMS in a timely manner. Collaborate with QMS Team and applicable QA… more
- Aequor (East Syracuse, NY)
- …third-party audits, and customer audits through participating in inspection readiness and addressing inspectional findings.Perform routine laboratory activities ... including sample management, instrument maintenance and calibration, inventory and ordering of supplies, general housekeeping, and other related activities.Work in a diverse group environment while focusing on inclusivity and safety to produce high quality,… more
- Repligen (Waltham, MA)
- …NCMRs: Identify and document nonconforming material detected during incoming inspection , production, or customer complaints. Ensure accurate logging of issue ... details, affected part numbers, quantities, and supplier information.Data Analysis and Trend Reporting: Analyze NCMR data to identify recurring issues, high-risk suppliers, and common failure modes. Generate trend reports and dashboards to communicate findings… 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 ... 5+ years of experience in GCP auditing. Substantial experience in inspection management. Substantial experience with US, EU, and international regulatory standards… 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 ... be responsible for providing support to the manufacturing area as part of the Operations team.This is a full-time position working Monday through Friday, dayshift (normally 8:00am-4:30pm) Applicant must complete and be medically cleared for BCG medical… 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 focusing on traceability, quality assurance, data conformance and data fitness. The position is a key collaborator with statistical programming, statistics, regulatory and… more
- Insmed Incorporated (San Diego, CA)
- …gene therapy products is preferred.Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare ... for inspections is required.Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is essential.Broad knowledge of risk-based quality systems approaches consistent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating ... review meetings and sponsor various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.Support organizational design updates, operations organization build, operations ramp-up of commercial and… more
