- Daiichi Sankyo, Inc. (Bernards, NJ)
- … audit process, to ensure information is documented and reported timely.Folder Audit includes: Review HCP Engagements that are considered closed according to ... and Department Head a monthly pass/fail report for performance managementMonthly full file audit includes: Review that all documents are uploaded and in the… more
- Merck & Co. (Lower Gwynedd, PA)
- …using various IT tools for laboratory testing/documentation (ELNs, LIMS, etc.), review , audit , and/or monitoring of quality metrics-Demonstrated history of ... writing (eg regulatory responses, SOPs, etc.), management of QA and regulatory inspections, review of data and lab processes, driving the evolution of systems and… more
- Aequor (South San Francisco, CA)
- Job Title: Senior Taxonomist - Content Review & Management Location: Onsite - South San Francisco (SSF) or Remote Contract Type: 6-Month Contract (with potential ... We are seeking an experienced and strategic Senior Taxonomist to support our Content Review and Management team. This is a 6-month contract role with the possibility… more
- Aequor (Tampa, FL)
- …to meet site requirements Ensure IT service SLAs meet site requirements - Review adherence to SLA by IT service delivery teams (systems availability, delivery of ... maintained in IT Applications repository database Internal and Regulatory Audit - Prepare and represent the site as the...requirements Ensure IT service SLAs meet site requirements - Review adherence to SLA by IT service delivery teams… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key Quality Indicators (KQIs). ... Affairs team, ensuring collaboration with other GxP QA functions (eg, GMP/IMP QA, Audit and Compliance, QMS QA, Development QA, and PVQA) to address GxP-related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received ... transfer of PV Business in case of Product Divestment. Collaborate with DSI audit groups to ensure comprehensive auditing of Business Partners as required to assure… more
- Eisai, Inc (Nutley, NJ)
- …use of funds, and economic trends. Additionally, this individual will review cash requirements, plans and prepare short-term investments/borrowings to optimize daily ... coverage) for a marketed product across all relevant insurance lines; Lead audit calculations for premium adjustments; Manage the end-to-end process of claim… more
- Merck & Co. (Lower Gwynedd, PA)
- …as subject matter expert with internal or external teams and during audit on molecular methods and platforms (eg, Quant Studios, KingFishers) and associated ... lab automation-Accountability for generated data. -May review data generated by others-Understand and apply regulatory/compliance/scientific requirements relative to… more
- Merck & Co. (Rahway, NJ)
- …summarizing results and work with area to ensure resolution of audit findings. Notifies relevant management of unresolved issues/trends.-Specific and/or additional ... Duties include compliance oversite of program-related activities, batch record review and approval, deviation and/or out-of-specification approval, etc.Identify need… more
- Merck & Co. (Durham, NC)
- …Global Vaccine Technology (GVTE), Automation, and Quality approvers.-Perform a thorough review of design & engineering records and related Good Manufacturing ... in a timely manner, and implementing corrective actions to improve the execution/ review process for equipment.Develop training material. Working as a subject matter… more
- Repligen (Waltham, MA)
- …Compile Quality metrics as inputs for monthly KPI's and management review meetings with the Senior Management team.Facilitate operational excellence initiatives in ... Quality Assurance.Maintain internal and external audit schedules; serve as host for site auditsMaintain risk-based strategy for overall Quality compliance across the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …documentation (specifications, protocols, reports). Review and approve periodic review documentation for qualified equipment/systems ( audit trails, user ... oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …objectives and implementation of process improvements.Contribute to the development and review of regional / global policies and procedures. Ensure compliance with ... developing and overseeing the implementation of CAPA in relation to sponsor's audit or regulatory inspections and ensure lessons learned are developed and… more
- Eisai, Inc (Nutley, NJ)
- …of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This ... US, EU Directives, US FDA, PMDA, ICH). Essential Functions Independently conduct audits Review and oversee results of CQA audits of study sites, clinical vendors,… more
- Monster (Camden, NJ)
- …with personnel. Initiate and follow-up on Internal Corrective Action Reports for the audit program. May support the Material Review Board (MRB) as needed ... this position will take a lead role in quality systems coordination, Internal Audit Planning, and QMS Document reviews, updates, and migration of Command Media… more
- UNC Health (Chapel Hill, NC)
- …that enhance operations and compliance. Familiarizes self with area under review , and if necessary, visits department/facility to gain operational and process ... coding guidelines and CMS policies. Assists in preparing annual audit and work plan. Performs work outlined in work...and analyzes data. Identifies and evaluates the area under review , identifying and documenting areas of risk and vulnerability… more
- Monster (Bernards, NJ)
- …and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received ... transfer of PV Business in case of Product Divestment. Collaborate with DSI audit groups to ensure comprehensive auditing of Business Partners as required to assure… more
- Monster (Atlanta, GA)
- …of carrying out most assignments typical of the profession with limited guidance or review . This level would be considered a promotional level and attainable by any ... storm events to clear rights-of-way for emergency responders. 4. Reforestation - Audit tree plantings to ensure survival or warrantied replacement of third-party… more
- Monster (Torrance, CA)
- …software quality processes in support of AS9100, CMMI, DO-178, and DO-254. Review program specific software related documents such as Software Development Plan, ... areas of improvement, and mitigate risks. Participate in Functional Configuration Audit (FCA), Stages of Involvement (SOI) and compliance audits for AS9100,… more
- Monster (St. Paul, MN)
- …events and meetings with residents to develop a positive sense of community. Audit and enter all invoices for payment. Fully investigate any questionable invoices. ... Department to help site meet requirements of Crime Free Multi-Housing program. Review monthly Operating Report to track income and expenses over time. SUPERVISORY… more
