- 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …finishing operations.Job Responsibilities: Monitors pharmaceutical operations in daily inspection activities to ensure personnel are following procedures Perform ... QA inspection of finished drug product units and samples for...to pharmaceutical Operations and perform acceptance quality limit (AQL) inspection Perform Quality Assurance compliance review of manufacturing, maintenance,… more
- Merck & Co. (Durham, NC)
- …drug product, including biotech culture growth, harvest, lyophilization, product inspection , and quality control laboratories.The Quality Assurance Manager will ... compliance to Durham Site policies and procedures that promote Permanent Inspection Readiness (PIR).Consults on an as-needed basis with next level manager… more
- Merck & Co. (Durham, NC)
- …drug product, including biotech culture growth, harvest, lyophilization, product inspection , and quality control laboratories. - The Specialist, Technical Operations ... documents necessary for engineering studies, change control. Supports regulatory inspection activities for the facility Provides on-the-floor support of operational… more
- Merck & Co. (Rahway, NJ)
- …to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the ... of device development and commercialization, product approval, and/or regulatory inspection experience with medical devices.Must be able to work independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across Daiichi Sankyo compounds with a focus on oversight, lessons learned and inspection readiness.Lead assessment of training needs and ensure delivery of RBQM CSM ... junior staff to ensure proper implementation and execution of RBQM and inspection readiness.Review and determine acceptability of CRO / vendor RBQM practices and… more
- Merck & Co. (Durham, NC)
- …trending. Support QO Lab, Sterility Assurance, EMSS, and Warehouse pre-approval inspection (PAI) readiness activities.- Support QO Lab, Sterility Assurance, EMSS, ... compliance of Building 160's policies and procedures that promote Permanent Inspection Readiness (PIR).- Participate in periodic site GEMBAs (walk-downs) as part… 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)
- …of identified access discrepancies per study to maintain overall compliance and inspection readiness of the application. This position will establish and maintain ... timely processing of access requests in accordance with our GSOP/GSOI and maintain inspection readiness of the documents in partnership with the study data managers.… 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)
- …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)
- …with preventing product/label mix-upsPerform activities to support the inspection , packaging, labeling, packing, palletizing, cleaning, reconciliation, traceability, ... (corrective lenses permitted) as demonstrated by a current eye exam for inspection activitiesEducation and Experience Requirements: High School diploma / or GED… more
- HEPCO, Inc. (Minneapolis, MN)
- …role, you will support the design, development, fabrication, assembly, testing, inspection , troubleshooting, rework, and repair of complex electronic products and ... and mechanical drawings. Experience with fabrication, assembly, testing, and inspection of electrical components. Skilled in assembling, reworking, and repairing… more
- Novo Nordisk Inc. (Durham, NC)
- …extremely cold work environment. 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 Bachelor's degree in engineering or a science… more
- Merck & Co. (Durham, NC)
- …processing of 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.Position Responsibilities:This role reports to the Operations Director and supports BCG production in Durham, NC. B160 production includes Drug Substance, Drug… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations, support and manage change controls and maintain permanent inspection readiness and actively support regulatory inspections. This individual will ... also support the implementation of manufacturing and process automation strategies through cell therapy manufacturing process design qualification, vendor evaluation, and enterprise system interface engineering support for GMP manufacturing of engineered… more
- Insmed Incorporated (San Diego, CA)
- …of phase appropriate quality requirementsResponsible for assisting in any Health Authority inspection preparation, acting as SME when needed and in providing or ... reviewing responses to findings from such inspections.Responsible for release or rejection of GMP materials and coordinate with QA staff to manage the timeline and assure on time delivery of approved materialsDevelop the required working relationships both… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …perform close activities such as: reading, writing, and analyzing; and visual inspection . The working environment includes a variety of physical conditions including ... noise, inside and outside conditions, working in narrow aisles, and temperature changes; atmospheric conditions including odors, fumes, and dust. Local and International Travel: 0-10%. We commit to an inclusive recruitment process and equality of opportunity… more
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