- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality improvement initiatives for development activities / programs post internal system audit . Support reporting of quality metrics for audits and inspections ... The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi… more
- Merck & Co. (Rahway, NJ)
- …Controller's Organization, Legal, and various operating divisions throughout our Company to support audit work and findings.Review and interpret IRS transcripts, ... transactions on future audits.-Prepare reports on the status of audit cycles for management. Support the Compliance team with FIN 48 reporting requirements and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... from the affiliate perspective when required. This role also provides direct support for continuous improvement initiatives, locally or globally driven, for the… 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
- Insmed Incorporated (San Diego, CA)
- …performed by Clinical Operations and Medical Departments. This role provides support and promotes collaboration internally to ensure all systems, processes and ... and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections and vendor audits.Ability to ensure… 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 ... rather than days. Over time, the same foundation you build will support dashboards, predictive analytics, and other data-driven tools that boost lab productivity… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Authorities and License Partners, Reconciliation with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical ... 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
- Twist BioScience (South San Francisco, CA)
- …standards, development, rigorous testing, validation, deployment, and post-go-live support for new and existing biomanufacturing facilities.System Optimization & ... Support : Drive continuous improvement and feature enhancement of existing MES functionalities, identify opportunities for process automation, electronic batch record… more
- Merck & Co. (Durham, NC)
- …Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This Individual will be-responsible ... in compliance with SDLC, GMP, safety, and environmental regulations.- Actively support , participate and embrace an empowered team culture including significant… more
- Repligen (Waltham, MA)
- …Generate trend reports and dashboards to communicate findings and support supplier development strategies.Continuous Improvement and Risk Mitigation: Drive ... assessments and quality audits. Experience with eQMS systems or digital audit tools Familiarity with regulatory standards (FDA, GMP, etc.). Excellent communication,… more
- Repligen (Waltham, MA)
- …reporting, including SEC filings support (10-Q, 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… more
- Repligen (Waltham, MA)
- …activities for product manufacture, test and release including deviation support , root cause analysis, customer complaint management, hosting customer/regulatory ... operational excellence initiatives in Quality Assurance.Maintain internal and external audit schedules; serve as host for site auditsMaintain risk-based strategy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …computer systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This ... risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility qualification,… more
- Twist BioScience (South San Francisco, CA)
- …reconciliation process, safeguarding the integrity of our significant accounts that support our financial records and controlsConsolidation of the monthly financial ... fixed assets, prepaids, and intercompany Govern the chart of accounts and support strategic initiatives by establishing the proper general ledger structure and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and relevant regulatory requirementsCoordinate with broader DS quality teams to support GRA meeting company policies for quality management (eg, completing ... ways of workingDrive activities required for GRA to be inspection ready, and support addressing any observations or findings that may result from audits and… more
- Serco (Washington, DC)
- …of our nation? Then Serco has the right opportunity for you! As the Audit Support Coordinator for the Submarine Safety and Quality Assurance Division (SEA ... positive impact supporting our military and the safety of our Sailors. The Audit Support Coordinator is an administrative support position that assists SEA… more
- Herbalife (Torrance, CA)
- Representative, Order Support Audit Category: Member Services/Customer Service Position Type: Regular Full-Time External ID: 16593 Location: Torrance, CA, United ... share to linkedin Apply Now **Overview** POSITION SUMMARY STATEMENT: The Representative, Order Support Audit will be responsible for managing high volumes of… more
- PNC (Charlotte, NC)
- …Manager Sr with Audit and/or Risk Management experience, to join Internal Audit 's Professional Practices team ( Audit Support and Administration team). ... to perform data procurement and analysis; prepares work papers to support complex, or higher-risk-based, and/or conclusion-based audit assignments with… more
- Pacific Seafood (Clackamas, OR)
- … team, providing guidance, training, and development opportunities. 5. Annual Financial Statement Audit + Support annual external financial statement audit ... and always striving to do better. Summary: The Internal Audit Manager is a new and key role at...training department(s) for design and execution of training. + Support regulatory and policy compliance, including coordination with external… more
- SHI (Somerset, NJ)
- …regarding the importance of maintaining strong internal controls and the role of internal audit . + Support the creation and enhancement of controls and processes ... Support the internal management attestation process over financial controls. + Support initiatives aimed at improving Internal Audit 's processes and… more
