- Merck & Co. (Rahway, NJ)
- Job DescriptionOverviewThe Associate Director of Federal Tax Audit plays a crucial role in supporting the audit function within the Tax Department, reporting ... Director of Tax Audits. This position is responsible for managing the audit process, developing strategies, and collaborating closely with the Internal Revenue… more
- Merck & Co. (Rahway, NJ)
- …continue advancing medical innovation and help improve lives.Our Company's Corporate Audit and Assurance Services' (MCAAS) primary purpose is to provide value-added ... independent and risk-based audit and assurance services.Position Overview / Function and ResponsibilityThe...to evaluate the adequacy of internal controls and deliver audit reports that add value to the area audited.Coaches… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities per audit program of GxP relevant audit ... and its partners as applicable ensuring the execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cause analysis, corrective action(s)/preventative action(s) (CAPA) in connection with audit and/or inspection responses, and ensure proper implementation across ... Operating Procedures (SOPs) Advanced knowledge and participation on internal audit /inspection readiness (ie FDA PADE inspection) Excellent interpersonal skills and… more
- Insmed Incorporated (San Diego, CA)
- …regulatory agency inspections and vendor audits.Ability to ensure that a strategic audit plan is developed, designed and implemented, and that the activities are ... to SOPs and regulations.Oversee GCP activities (including internal or external audit observations and development of adverse trends) to ensure patient safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... compliance with PV agreements.Participate in audit and inspection readiness activities. Provide input for re mediating PV system deficiencies cited in audit… more
- BioAgilytix (Durham, NC)
- …the last mile: turning those clean, validated data streams into the audit -ready files our pharmaceutical sponsors need on tight deadlines. You'll harmonize results ... to sponsors.Automate Delivery Workflows: Leverage RPA, scripted edit checks, and audit -trail capture to shrink cycle times and reduce defects.Enable Self-Service… more
- Repligen (Waltham, MA)
- …assessments and quality audits. Experience with eQMS systems or digital audit tools Familiarity with regulatory standards (FDA, GMP, etc.). Excellent communication, ... negotiation, and interpersonal skills. Willingness to travel for supplier audits and evaluations.What Repligen OffersRepligen offers you a competitive remuneration package, including a yearly bonus, non-contributory pension, generous PTO, partial compensation… more
- Twist BioScience (South San Francisco, CA)
- …data utilization. Ensure robust system performance, availability, and audit readiness through proactive monitoring and maintenance.Cross-Functional Collaboration: ... manufacturing data within the MES, critical for regulatory submissions and audit trails. Develop and implement robust reporting, analytics, and data visualization… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …reports, review and process a variety of employee deductions, prepare and audit quarterly tax returns, assist with the preparation and reconciliation of W-2 ... and other related tax statements, provide payroll-related customer service to internal and external customers, and perform all other related duties and tasks as required or assigned.QualificationsRequires a high school diploma or equivalent and a minimum of 5… more
- Merck & Co. (Rahway, NJ)
- …charges that are allocated to the cost centers they manage.Respond to all audit inquiries and requests from both internal and external auditors.Assist with other ... ad-hoc special projects as needed.Position Qualifications:BS degree or equivalent in Accounting required.Minimum 1-3 years of relevant experiencePreferred Experience and Skills: Understanding of General Ledger reconciliation processSAP experience in preparing… more
- Merck & Co. (Durham, NC)
- …ApplicableShift:1st - DayValid Driving License:NoHazardous Material(s):N/ARequired Skills: Audit Management, Automation Solutions, Business Process Improvements, ... Communication, Corrective Action Management, Data Management, Environmental Regulations, Environment Health and Safety, Fast-Paced Environments, GMP Compliance, Good Manufacturing Practices (GMP), Healthcare Innovation, IT Operation, Problem Management,… more
- Repligen (Waltham, MA)
- …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 cross-functional teams (FP&A, Tax, Treasury, etc.) to ensure accurate financial reportingAd hoc financial analysis… more
- Novo Nordisk Inc. (Langhorne, PA)
- …of regional resources to ensure attainment of profitability goals Review and audit expense reports Continuously improve the knowledge of Novo Nordisk products, ... competitive products, and management skills through ongoing home study and participation in company sponsored/approved training programs Execute regional level account targeting strategy in business unit to fulfill regional account targeting strategy… more
- Repligen (Waltham, MA)
- …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 organization and in support of the ISO 9001 standard.Review and approval of validation plans, deviations, failure investigations and corrective action plans prior to implementation when required. Review and approve New… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and approve periodic review documentation for qualified equipment/systems ( audit trails, user groups, system administration)Provide expertise and solutions ... to issues regarding qualification and validation strategies and documentationProvides guidance on industry best practices, and quality requirements for maintaining a compliant state for all site systems.Assist in the development of validation and qualification… more
- Twist BioScience (South San Francisco, CA)
- …impacting the Company's general ledger and control environmentSupport the annual audit and tax complianceDevelop scalable internal controls within the accounting ... function and intersections across the organizationFoster a control environment that rewards integrity and objectivity while ensuring all related internal controls are consistently adhered to and executed timely with precisionDrive process improvement in all… 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 ... role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (eg US, EU… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to resolve process deviations / CAPAs arising from either internal audit or HA inspection findingsWork with cross-functional stakeholders to enable sufficient ... input and buy-in being received where needed Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:Bachelor's Degree Data Science, Computer Science, Engineering, Statistics, or… more
- MUFG (New York, NY)
- …more details. **Job Summary:** The Senior Auditor I role within Internal Audit is responsible for leading independent, objective assurance and consulting activities ... limited to, independently owning the successful execution of the end-to-end audit process (eg planning, fieldwork testing, reporting, issues validation, etc.). The… more
