- Merck & Co. (Rahway, NJ)
- …Experience and Skills:A minimum of 3 years work experience in internal audit , public accounting, or general accounting.Experience with ... IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Accounting, Accounting, Adaptability, Asset Accounting, Audit Internal Controls, Contract Audits, Data Analysis,… more
- Eisai, Inc (Nutley, NJ)
- …enabler of business'; lead global initiatives for continuous improvement.Trend and leverage internal audit and industry intelligence relating to inspections and ... is responsible for design, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue… more
- Insmed Incorporated (San Diego, CA)
- …and reports written according to SOPs and regulations.Oversee GCP activities (including internal or external audit observations and development of adverse ... and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance (CQA)… more
- Repligen (Waltham, MA)
- …(SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to ... and quality audits. Experience with eQMS systems or digital audit tools Familiarity with regulatory standards (FDA, GMP, etc.). Excellent communication,… more
- Eisai, Inc (Nutley, NJ)
- …responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and ... make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is… more
- Repligen (Waltham, MA)
- …meetings with the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance.Maintain internal and external audit schedules; ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility...aspects of the QMS including but not limited to Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Change… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking a QA Shop Floor Specialist II/III as part of the Quality Operations team based in Raritan, New Jersey. Role OverviewThe QA Shop Floor Specialist ... is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation… more
- Aequor (Davie, FL)
- …the experimental and process confirmation studies in coordination with planning, manufacturing, quality , LTS and PM groups. Review and analysis of the analytical and ... development/ scale up of the ANDA lots. Participation in internal (Corporate and QA audits) and external (FDA, MHRA)...audits) and external (FDA, MHRA) audits. Remediation of the audit related observations (if any) and timely completion of… more
- Merck & Co. (Lower Gwynedd, PA)
- …and maintain a constant state of inspection readiness.-Participate in regulatory or internal QA audits-Monitor lab operations and quality metrics, identifying ... on maintaining adherence to SOPs and documentation requirements.-Participate or lead internal initiatives that result in quality operations-Required Experience &… more
- Merck & Co. (Lower Gwynedd, PA)
- …various IT tools for laboratory testing/documentation (ELNs, LIMS, etc.), review, audit , and/or monitoring of quality metrics-Demonstrated history of developing ... and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data. -A combination of molecular (eg, PCR), serology… more
- Merck & Co. (Lower Gwynedd, PA)
- …and clinical sample analysis within a GxP laboratory-Act as subject matter expert with internal or external teams and during audit on serology methods and ... and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data. -A combination of molecular (eg, PCR), serology… more
- Genscript USA Inc. (Piscataway, NJ)
- …with cross-functional teams is essential to ensure supply continuity, compliance with quality and regulatory standards, and readiness for audit requirements. The ... processes remain compliant with company policies and regulatory standards. Respond to internal and external audit challenges by providing complete and accurate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor governance bodies and ensure ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust ... studies are conducted according to the timeline, budget and quality measures set forth by the Study teams. This...overseeing the implementation of CAPA in relation to sponsor's audit or regulatory inspections and ensure lessons learned are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …local MES system.Align global process strategy and data governance initiativesEnsures Audit Readiness and SupportResponsible for the site system strategy and ... and performance management of MES team.Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within… more
- grabjobs (Arlington, VA)
- …Microsoft Office Suite, SQL, and DAX. Review and lead the analysis ofdata and audit requests from end users and compile the requested data from Momentum financials ... and data tools from Momentum financials and other VA systems. Lead analysis on the quality of data in Momentum financials and test the migration of data from FMS and… more
- Tenethealth (Frisco, TX)
- …be assigned. Performs diagnosis data submissions to Client, Vendors and internal Stakeholders Develop monthly productivity and revenue projections Responsible for ... Prepares data collection reports for leadership Monitors diagnosis submission progress; Audit diagnosis submission files to ensure accuracy Reviews, analyzes and… more
- grabjobs (Washington, DC)
- …complex SQL queries to support operational and performance reporting, including audit system log analysisBuild and maintain reusable Python scripts for parsing ... Year and Compliance reportingPerform data profiling and analysis to identify data quality issues, data gaps, and potential risks for mitigationDefine and enforce… more
- Monster (Seattle, WA)
- …success while representing the client's interests. You'll collaborate closely with internal stakeholders and contracted vendors to deliver smooth implementations and ... vendors accountable for delivering contracted scope, schedule, budget, and quality , ensuring performance is tracked and issues escalated/resolved *Coordinate… more
- Monster (Norfolk, VA)
- …report formats for the Company and various stakeholders. * Manage the external and internal audits and ensure that audit reports are issued in line with ... our extensive international shipping network. With the combination of high- quality intermodal operations and advanced technology, equipment, and e-commerce, APL… more
- Jabil (St. Petersburg, FL)
- …internationally; 1-2 weeks per quarter, as needed.What Will You Do?. Lead and execute individual Internal Audit projects as part of the overall audit plan. . ... the globe. How Will You Make An Impact?The Senior Internal Auditor in Quality is in charge...the department through the Research and Innovation Lab in Internal Audit . Execute project plans and act… more
