- Merck & Co. (Rahway, NJ)
- …is seeking a highly motivated Scientist- GMP Microbiology Investigation Support /Data Reviewer to join the growing Microbiology Center of Excellence (COE).- Based at ... utility (environmental/water) deviations. This position will also be required to review GMP microbiological data from product and utility testing. -While working… more
- Merck & Co. (Rahway, NJ)
- …chain deliverables and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Works directly in the SAP ... Product and Clinical Finished Goods).- - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply… more
- Merck & Co. (Rahway, NJ)
- …milestones, and risks within our Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) ... analytical test method technology transfer process.Skilled in laboratory good documentation practices and electronic documentation systems.Self-motivated with… more
- Merck & Co. (Rahway, NJ)
- …providing high-level commentary and providing estimates for recurring events to major stakeholders. Review and ensure accurate data is reported per plant in monthly ... and/or increase efficiency.Continue to meet the S404 requirements, updating documentation and performing/enhancing existing controls.Analyze standard revision on global… more
- Merck & Co. (Rahway, NJ)
- …nomenclature data into a centralized databasePerforming data integrity review activities, including proofreadingDeveloping rules to ensure data qualityContributing ... FAIR principles and other standardsExperience writing and maintaining process documentation #eligibleforERPCurrent Employees apply HERE Current Contingent Workers apply HERE… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to assure all external contractors provide GMP compliant product release documentation . Participates as a cross-functional team member to provide product quality/GMP ... support and assures proper documentation of drug product release programs in accordance with...for commercial and IMP relevant activities and QA batch review and release process as necessary.Complaint and Recall Programs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …EU. Preparation of updated Core Data Sheets, and EU and US Documentation : Independently manages, prepares and implements regulatory documents (eg, USPI, annotated ... CCDS; Ensures implementation of CCDS/labeling agreements with licensing partners.Conduct Label Review Committee Meetings: Prepares documents for review by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …users to roles based on authorized requests from study team members, periodic review of user access and audit trail reconciliation, impact analysis and ... documentation of identified access discrepancies per study to maintain...traceability of data access requests, procedures for the periodic review , and process improvements. This position will also work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Under the direction of the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create and modify Structured Product ... listing, track and archive affiliate labeling for global products and review proposed labeling from affiliates. ResponsibilitiesProvide Regulatory support in the… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …analysis of tumor samples and tissues from mice and NHPAnalyze, summary, review and present dataParticipate in assay development and qualificationMaintain good ... documentation in ELN, paper notebook and log books.Perform additional exploratory and investigational studies with various techniquesRequirements Ph.D. or Master… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team adherence to the CSOP and manage the overall implementation and documentation of the CSOP, including activities conducted by CROs and vendors.Provide ... input into study protocol profiles, final protocols and amendmentsLead document review & coordination for the protocol and amendments. Additional medical writing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship.Assists in ... master label text, translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the quality and timely delivery of programming deliverables, including integrated data review plan (IDRP), study data listings and exception reports, sample data ... relevant guidelines. Accountable for inspection readiness of DM programming documentation filed/archived according to applicable Daiichi Sankyo and regulatory… more
- City of New York (New York, NY)
- … Reviewers who will: Facilitate participant intake process, including collection and review of documentation required to obtain approval in education and ... One Viewer system, including data entry and retrieval on computerized systems. - Review records processed by the unit, identifying errors, and indicating need for… more
- City of New York (New York, NY)
- … for both sustainability and resiliency; LEED compliance strategies; and certification documentation . The Sr. Design Reviewer will also be responsible for ... Department of Design & Construction, Public Buildings Division seeks a Sr. Design Reviewer to join the Sustainability Unit. The selected candidate will serve as one… more
- City of New York (New York, NY)
- …for (1) one Principal Administrative Associate II to function as a Quality Control Case Reviewer , who will: - Ensure the accuracy of the review sample by ... conducting preliminary WMS inquiries and case review ; utilize reports to verify that sample is auditable;...case records requested by external auditors and identify missing documentation and processing errors that could result in negative… more
- City of New York (New York, NY)
- …care (NAMI-Net Available Monthly Income) if institutionalized. - Interview and/or review documentation submitted by applicants/recipients (A/R) or authorized ... representatives, to determine eligibility for Medicaid. - Conduct a comprehensive review of applications including financial and legal documentation , as well as… more
- City of New York (New York, NY)
- …third-party contacts to clarify and identify any variances, discrepancies or inadequate documentation discovered during the review of State Quality Control ... II to function as a Quality Control Case Reviewers, who will: - Review POS, HRA One Viewer of imaged/scanned documents, Welfare Management System (WMS) data… more
- City of New York (New York, NY)
- …by the New York State Office of Temporary and Disability Assistance (NYSOTDA). Review the corrective action memorandums and supporting documentation on State ... Associate III to function as a Quality Control Case Review Supervisor who will: - Supervise and provide guidance...Monitor the preparation and submission of detailed correspondence and documentation to be sent to New York State Quality… more
- Merck (Rahway, NJ)
- …is seeking a highly motivated Scientist- GMP Microbiology Investigation Support /Data Reviewer to join the growing Microbiology Center of Excellence (COE). Based at ... utility (environmental/water) deviations. This position will also be required to review GMP microbiological data from product and utility testing. While working… more
