- Aequor (Tampa, FL)
- …tax compliance and reporting for the region, encompassing transfer pricing documentation , intercompany transaction analysis, and tax provision support . This ... schedules for permanent and temporary items to ensure accurate reporting. Preparer documentation to support the analysis of profitability templates and defense… more
- Merck & Co. (Rahway, NJ)
- …Quality Operations - API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API ... accurately reflected. Assist in SOP and quality-related system document approval. Support metrics by summarizing findings during documentation reviews. Collect,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, ... computer systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This… more
- Repligen (Waltham, MA)
- …in the preparation of internal and external financial reporting, including SEC filings support (10-Q, 10-K)Maintain documentation to support SOX internal ... control complianceParticipate in audit requests from internal and external auditorsSupport accruals, prepaids, fixed assets, and other assigned accounting areasAssist in implementing process improvements and enhancing operational efficiencyCollaborate with… more
- Aequor (Athens, GA)
- Tech-savvy information management specialist to support GI Development sites / activities. Major activities include: the subject matter expert for electronic ... documents, regulatory submission documents): Create and configure document templates and support site users in workflow configuration. Provide routine user … more
- Merck & Co. (Rahway, NJ)
- … such as master inventory lists, qualification documentation , calibration documentation , computer system inventories Support internal and external quality ... audits and maintain laboratory state of permanent inspection readiness Author or contribute to Standard Operating Procedures (SOP) draftingOriginate and own Investigations and Change Management recordsThe successful candidate must function both independently… more
- Aequor (Thousand Oaks, CA)
- …the lab, checking to ensure removal of expired media performed, archiving documentation , preliminary plate readings etc. Support Microbiology lab with analytical ... Exposure to GMP and Aseptic technic and benchwork experience. Lab work. Support Microbiology lab with analytical testing. Pipetting water testing, Observing for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …This role will be part of our manufacturing downstream purification process support team, dedicated to one of our manufacturing suites. Responsible for assisting ... Engineer I will work alongside Process Associates and Process Scientists to support day to day issues in manufacturing related to: deviations, equipment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Operations Support Specialist, Sun-Wed 2nd Shift as part of the Technical Operations ... team based in Raritan, NJ. Role OverviewThe Operations Support Specialist will be part of the Technical Operations team responsible for the production of a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This ... for coordinating the authoring, review and approval of new or updated procedural documentation . In addition, this role will work closely with process owners, subject… more
- Merck & Co. (Rahway, NJ)
- …Information Management organization.Primary area of responsibilities will include:Project support for System Development, Maintenance, Enhancement and System ... pathways to ensure limited impact to delivery timelines for workstream activities. Support the development of User facing System Resources ensuring supporting… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, start-up, conduct and close-out) ... the direction and supervision by study Clinical Operations Lead(s). Plans, support , creates, and communicates clinical study timelines. Gathers input from… more
- Eisai, Inc (Exton, PA)
- …pilot plant, including scheduling of staff, preparation and close-out of documentation , manufacture of DS/ADI materials, and suite change-over ensuring compliance to ... validation protocols and reports, and SOPs, along with providing supporting documentation . They formulate the overall strategy for Upstream and Downstream Operations… more
- Merck & Co. (Durham, NC)
- …Technician is responsible for providing equipment troubleshooting and maintenance support to VMF Operations areas (sterile supply, weigh/dispense, media, ... production equipment in a clean room environment. Responsible for written documentation of activities.- Actively supports, participates and embraces an empowered… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily ... to the supply network and existing commercial products undergoing process optimization. Support is inclusive of both start-up operations (FLEx Sterile1) and new… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in Raritan, NJ. Role OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy ... This individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and compliant manufacturing… more
- Merck & Co. (Durham, NC)
- …Technician is responsible for providing equipment troubleshooting and maintenance support to VMF Operations areas (sterile supply, weigh/dispense, media, ... production equipment in a clean room environment. Responsible for written documentation of activities.- Actively supports, participates and embraces an empowered… more
- Merck & Co. (Rahway, NJ)
- …drive overall success and performance of the building, and ultimately strong support for the overall SM PR&D pipeline. Responsibilities: Under the scientific ... of the facility.Ensure facility readiness with respect to cleaning (including documentation and execution), dummy run and batch execution, building housekeeping, and… more
- AUROBINDO (Durham, NC)
- …history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has give Aurolife a jump start ... world to live in.Job OverviewThe Human Resources Business Partner will provide support in the following functional areas (but not limited to): recruitment, benefits… more
- Merck & Co. (Durham, NC)
- …warehouse operations and efficiency.- Additional responsibilities will include qualification support of off-site warehouse facilities for ambient and -70 storage ... Logistics and Operations managers and personnel as a subject matter expert (SME) in support of training and implementation of any new projects.- This includes SME … more
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