- Aequor (Salt Lake City, UT)
- …mechanisms including routine line checks, line clearance activities, in-process inspection oversight, providing general guidance and instruction to correct ... that are being reviewed such as artwork, raw material files, AQL inspection forms, and labeling. Responsible for performing additional related duties as assigned.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the Global RD/PV QA team. May be assigned other Inspection Management Team (IMT) roles in support of inspection preparation, facilitation, ... of ongoing review of risks by evaluating Quality Events (QEs), audit, and inspection outcomes so these data may be shared with the relevant business functions… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …audit actions related to the siteEnsures and maintains a state of inspection readiness.Perform compliance walkthroughs as part of audit/ inspection readiness ... activities to ensure that the site is an inspection ready state.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordinate SOP Training and effectiveness beyond Read and Apply training in LMS. Inspection Readiness Provide support for audits, inspections and inspection ... requirements related to global health authority inspections, participation in inspection activities and finding remediation preferredDemonstrate ability to combine… more
- Merck & Co. (Durham, NC)
- …areas (sterile supply, weigh/dispense, media, stabilizer/prep, Drug substance, filling, capping/ inspection , clean utilities etc.) located in aseptic and clean room ... related equipment (eg Autoclaves, Fillers, Lyophilizers, Cappers and Automated Inspection Machines, Isolators.) The ability to satisfactorily perform all types… more
- Raytheon (Tucson, AZ)
- …work performed is properly and completely documented and ready for use. Verification and inspection may be required, and candidate will need to be able to identify ... extensive period. Build cables and harnesses from schematics. Quality verification and inspection under a microscope Identify, repair, and replace wire harnesses and… more
- Aequor (Bothell, WA)
- …hands-on operations in the areas of shipping of GMP material, receiving, inspection , storage, transferring and issuing inventory of materials, drug substance in ... intermediates and QC samples with IATA/DOT 19 CFR Certification. Receipt, inspection and quarantining of GMP raw materials and manufacturing aides. Material… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …budget is reconciled with Finance on an ongoing basis.Support all inspection readiness and quality initiatives pertaining to assigned stud(ies).Ensures trial master ... Coordinate and liaise with Daiichi Sankyo QA on site audit and inspection activities.Conduct and/or oversee the CRO oversight monitoring visits (CROOM visits) as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key issues identified.Participate in or support internal audit and regulatory inspection activities related to site monitoring and sponsor oversight.Contribute to ... of the study processes and other procedures and ensure sites are inspection ready.Contribute to SOP updates. Qualifications: Successful candidates will be able to… 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)
- …for health and control processes. Leads Digital QMS audit & inspection readiness, deviations and change control activities Manage Organizational Change Management ... Experience with risk-based Supplier Quality Management process. Management of Global Inspection and Audit programs Proficient working on multiple projects in a… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and troubleshooting the networking systems for automated utility, processing, filling, inspection and packaging equipment. The system utilized will be PLC, SCADA, ... software for new automated utility, process, filling, and packaging and inspection equipmentPrepare a preferred vendor list for control system hardwareGenerate user… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …the finishing team to perform responsibilities associated with inspection , packaging, labeling, packing, palletizing, cleaning, reconciliation, traceability, ... lenses permitted) as demonstrated by a current eye exam for inspection activitiesEducation and Experience Requirements: High School Diploma or equivalent required;… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …team in Lenoir, NC. The QC IRMI Technician is responsible for performing QA inspection , sampling, AQL, and release labeling of raw materials to be used in ... production. Job Responsibilities Perform QA inspection of incoming raw materials prior to their use in productionPerform AQL sampling and sampling breakdown of… more
- Merck & Co. (Durham, NC)
- …chemical handling and biosafety level regulationsMaintaining labs in an inspection -ready, cGMP-compliant state and represent the laboratory during audits and ... inspections (regulatory, internal, safety)Build and maintain strong relationships with site leadership, stakeholders, and customersApplies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and… more
- Merck & Co. (Rahway, NJ)
- …tests within specified windows for the North American GMP Operations team.Ensure inspection readiness and offer prompt support during regulatory, quality, and safety ... inspections.Address audit findings and identify trends to enhance laboratory compliance.Conduct laboratory investigations and collaborate with stakeholders to implement corrective or preventative actions.Develop and track internal compliance metrics and report… more
- Genmab (Plainsboro, NJ)
- …and change controls in connection to Clinical Drug Supply OperationDrive Inspection and Audit preparation and executionResponsible to be compliant with Genmab's ... quality systemRequirementsMinimum a Bachelors with 3-5 years experience. Master's degree with +2 years experiences, or PhD's degree with +1 year of experience, or equivalent of experience.Experience in handling supply chain, manufacturing, ERP, clinical supply… more
- Merck & Co. (Durham, NC)
- …Collaborates with Operations, Technology and Quality to author regulatory inspection observation responses and completes remediation projects, as required. Assists ... shift managers in providing leadership to the production floor. Capable of providing primary leadership to team during extended periods of manager absence such as vacationsServes as liaison between the team and support groups in resolving day to day issues and… more
- Genmab (Plainsboro, NJ)
- …projects within the area of clinical drug supply management.Oversee inspection readiness and ensure compliance with relevant regulations.Manage operational trial ... and project objectives, providing proactive oversight to meet goals.Develop, maintain and implement SOPs for drug supply processes and manage cross-functional collaborations.RequirementsYou hold a Bachelor's degree in a relevant area (eg, pharma, science,… more
- Novo Nordisk Inc. (Durham, NC)
- …extremely cold work environments. Occasionally positions oneself within confined spaces for inspection , repair & maintenance of equipment. Ability to work in loud ... noise environments with hearing protection. Occasionally works in outdoor weather conditions. Able to pass a driving exam for powered industrial trucks. Does not require a valid driver's license. Qualifications High School Diploma required Current enrollment… more
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