- Eisai, Inc (Nutley, NJ)
- …Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality management system. This role ... for the country/region in scope (including audit and inspection management, issue management, and oversight of the quality management system).Conduct complex audits… more
- Merck & Co. (Durham, NC)
- …solving. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) ... in order to best understand and identify root cause and then fix then fix implement corrective and preventative actions to prevent repeat failures.Responsible for the identification, development, and implementation of new systems which enhances the operation… more
- Merck & Co. (Millsboro, DE)
- …shipping including handling of dry ice and/or liquid nitrogen.Receive and issue materials from inventory.Perform cycle counting.Organization & storage of direct ... materials.Operation of company vehicle, forklift and/or pallet jack.Assist with equipment set-up and operation.Proficient in computer use, ie Microsoft Word and ExcelMaintain data in SAP.Attend training classes, workshops, meetings, etc. as required to improve… more
- Merck & Co. (Durham, NC)
- …as necessary.The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) ... in order to best understand and identify root cause.Provide input to investigate deviations, with responsibility to interface with approvers.-Efficient and safe maintenance and repair of equipment using Hazardous Energy Control ProceduresRequired to wear… more
- Merck & Co. (Durham, NC)
- …Safety Compliance:The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and ... people) in order to best understand and identify root cause.Efficient and safe maintenance and repair of equipment using Hazardous Energy Control ProceduresRequired to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats,… more
- Merck & Co. (Durham, NC)
- …based on transfer request requirements on a first expiry, first out (FEFO) basis. Issue materials in SAP via Inventory Transaction Entry.Receive material in SAP via ... Inventory Transaction Entry.Performs required data entry functions in SAP to execute the receiving/shipping processes.Operates forklift or powered lift to load onto freight truck.Perform regular cycle counts, ensuring system inventory accuracy.Education… more
- Merck & Co. (San Diego, CA)
- …team for timeline management, risk identification and mitigation, issue resolution.-May facilitate and collaborate with key internal/external stakeholders ... (eg, study team, country teams, vendors, committees) in support of clinical study objectives.-Accountable for managing any study specific partners and/or vendors.-Core SkillsDemonstrated ability to drive and manage operational activities on clinical protocols.… more
- Eisai, Inc (Miami, FL)
- …and Eisai's patient support programs. In the event of an access or reimbursement issue , this role will quickly identify and triage, as needed, the situation to ... appropriate internal or external Eisai partners and manage the communication until appropriate resolution. This role will have a keen understanding of payer coverage at the customer and regional level and strong communication skills to appropriately educate on… more
- Insmed Incorporated (San Diego, CA)
- …programsProvide strategic regulatory guidance and input in problem solving and issue resolution, etc.Develop risk mitigation plans for key partnersProvide regulatory ... review of documentation prepared by other technical functions supporting product development activities (eg, clinical protocols, clinical study reports, statistical analysis plans, etc.) in accordance with regulatory guidelines/requirementsProvide leadership… more
- Insmed Incorporated (St. Louis, MO)
- …may include trial site identification, ongoing recruitment motivation, and issue /problem solving.Provide medical and scientific support to payers, commercial managed ... markets, and related health care organizations to facilitate access to Insmed's medications for appropriate patients. Demonstrate strong competency in medical and scientific exchange to healthcare organizations. Deliver and implement effective product and… more
- Repligen (Waltham, MA)
- …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 and support supplier development strategies.Continuous Improvement and Risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study teams. This level handles escalated global CSPV case processing issue and handles project. This position prepares trainings, supports CAPA investigations, ... case review, documentation reviews in collaboration with the ICSR management and CRO/Vendor oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports… more
- Citigroup (Jacksonville, FL)
- Individuals in Issue Management are responsible for the coordination and comprehensive management of issues with key stakeholders, such that Citi achieves and ... coordination and comprehensive management of issues with key stakeholders + Support issue quality reviews ensuring compliance with Issue Management Policy,… more
- Truist (Atlanta, GA)
- …against the commitments made in the remediation plans. Teammate will help Issue Execution Officers and business units incorporate any observations from 1LOD review ... and assurance into remediation timelines prior to issue closure. Issue Assurance Specialist will support in the creation of the closure memo that articulates the… more
- Citigroup (Getzville, NY)
- Individuals in Issue Management are responsible for the coordination and comprehensive management of issues with key stakeholders, such that Citi achieves and ... consideration of lessons learned for the timely closure of issues. The Issue Management Quality Assurance Director is a senior management position within the… more
- Truist (Charlotte, NC)
- …against the commitments made in the remediation plans. Teammate will partner with Issue Execution teammates and business unit issue owners to identify ... assurance review that may impact ability to close the issue including revisions to remediation plans or artifacts. ...issue including revisions to remediation plans or artifacts. Issue Assurance Specialist will support creation of the closure… more
- Truist (Atlanta, GA)
- …following job description:** The Issues Assurance Officer is responsible for reviewing issue remediation artifacts related to moderate or lower complexity issues for ... effectiveness of implemented controls. The Issues Assurance officer will assist issue owners in integrating observations from inline assurance reviews throughout the… more
- American Express (Phoenix, AZ)
- …the future success of American Express. The Compliance Manager- Banking Product Issue Management will ensure our Consumer Deposit Products (Checking, Savings, and ... Compliance and business partners to identify potential issues, influence decisions about issue management, and manage Issues and Events through closure + Drive… more
- Citigroup (Getzville, NY)
- Individuals in Issue Management are responsible for the coordination and comprehensive management of issues with key stakeholders, such that Citi achieves and ... and quality execution of QA reviews across assigned portfolio in compliance with Issue Management Policy, Standards, and Procedures. + Act as a key resource for… more
- The Boeing Company (Berkeley, MO)
- …future with us. The Boeing Company is currently seeking a **Sapphire Risk Issue Opportunity Senior Project Manager** to join the team in Berkeley, MO; Hazelwood, ... BDS and Boeing Information Digital Technology and Security (IDT&S). The Sapphire Risk, Issue , Opportunity (RIO) Senior Project Manager is the program's central Risk … more
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