- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, CMC audit , clinical/IMP vendor audits and overall GMP vendor audit program . Establish lessons learned from audits/inspections to drive continuous ... Ensure effective collaboration with DS affiliates to promote a culture of quality that drives performance and teamwork.Responsibilities:GMP Audit : Support the… more
- USAA (Plano, TX)
- … deliverables, and may provide engagement evaluations. Provide input into the internal audit universe and risk profiles, updating risk assessment information. ... a complex operational and regulatory environment. Broad and comprehensive experience in Audit theory, internal audit principles with demonstrated experience… more
- AdaptHealth LLC (Philadelphia, PA)
- … Auditor - Business Systems is responsible for supporting and executing internal audit engagements, initiatives, and projects across the organization. This ... independently while contributing to team objectives, with skills to improve internal audit processes Requirements: Education and Experience Requirements:… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …program implementation across all sites.Manage and support the implementation of the internal and external audit program .Schedule, execute, report and ... management of the electronic systems for this program .Work with External Quality and other internal functions to understand and mitigate any compliance… more
- Merck & Co. (Durham, NC)
- … Associate Director/GMP Lead Site Auditor will have leadership responsibility for the site internal audit program , encompassing the full scope of site ... leadership, regional compliance leadership and Divisional Quality Assurance to elevate site audit program to achieve excellence and ensure program is… more
- Insmed Incorporated (NJ)
- …Veeva Quality Management System to ensure alignment with regulatory and internal quality standards.Work closely with Quality Assurance, Regulatory ... we're in. Are you?About the Role:We're looking for a Quality Management System (QMS) Specialist on the Analytical Development...of CAPAs, deviations and change controls.Serve as a key audit contact point by assisting with documentation and report… more
- Harbor Health Services, Inc. (Mattapan, MA)
- …quality improvement through communication of practice standards, PACE, and through an internal quality assurance program that measures vendor performance. ... Plan Programs of All-Inclusive Care for the Elderly, a program that allows frail elders to live in their...are currently seeking a Director of Utilization Management & Quality Programs. Harbor Health offers an excellent, comprehensive benefits… more
- Repligen (Waltham, MA)
- …over financial reporting and key digital systems. This role drives the ITGC audit program , advises on risk mitigation strategies, and partners closely with ... Internal Audit , IT, Financial Reporting, and external...ITGC and SOX processes.Utilize data analytics to enhance testing quality , reduce risk, and improve audit coverage.Stay… more
- Sanofi (Swiftwater, PA)
- …Parties, outlining quality expectations and responsibilities. Establishing an annual audit program of third-party facilities to assess compliance with ... quality systems and capabilities. You will develop quality agreements, establish audit programs to assess...applicable regulatory requirements (GMP / GDP) and internal documents. Identifying and mitigating risks associated with Third… more
- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- … Program , Corrective Action & Prevention Action (CAPAs) Program and the Internal Audit Program . Conducts internal and supplier audits, writes ... of Quality Operations in maintaining an effective Quality Assurance (QA) program , and GMP ... audit reports, issues CAPAs and trains internal auditors to conduct these activities. Conducts regulatory reviews… more
- USAA (Tampa, FL)
- …corrective action, validation, closure) and maintain the Operational Loss program (event collection, categorization, root-cause attribution, data quality , ... and reporting. Familiarity with financial services regulations (eg, OCC/FFIEC) and audit practices. Ability to produce high- quality evidence and documentation… more
- Jars Cannabis (Troy, MI)
- …collaboration. Implementing a progressive approach, we aim to provide only the highest quality of product and service to our customers and the communities that we ... booking, distributions, and retained earnings tie-outs. - Develop and enforce internal controls, approval processes, and standard operating procedures for all… more
- Cipla (Fall River, MA)
- …with the evolving business requirements. SAP Support for Production, Warehouse and Quality Handling Audit Trails, CSV activities Network Administration, Software ... Systems Implementation, Validation, Administration etc., for Manufacturing, Packaging, Warehouse, Quality etc., IT project coordinator role and stakeholder management… more
- Cipla (Hauppauge, NY)
- …with Good Manufacturing Practices (GMP) and regulatory requirements. Participate in internal audits and ensure compliance with warehouse quality standards. ... 5:00pm Job Overview: The QA Inspector (Warehouse) ensures the quality and compliance of printed packaging materials and warehouse...this position may be eligible for benefits and participation in a bonus program based on performance and company… more
- USAA (Charlotte, NC)
- …with Compliance and Risk Management, as well as Business Operations, IT, Audit Services, and Regulators to support risk and compliance-based initiatives. Responsible ... effectiveness, identifying control failures, facilitating risk and compliance remediation, internal and external audits and regulatory exams, and monitoring of… more
- Insmed Incorporated (NJ)
- …operational performance data to identify trends and opportunities for continuous improvement.Oversee quality control and audit readiness, serving as a subject ... compliance with company policies and regulatory standards, and the quality and integrity of all reviewed materials. By driving...matter expert on medical review operations during internal and external inspections.Who You Are:You have a Bachelor's… more
- Insmed Incorporated (NJ)
- …and maintain KPIs, scorecards, and governance frameworks for both internal supply operations and external partnersServe as clinical supply representative ... Clinical Supply Chain to ensure compliance with eTMF documentation and audit readiness activitiesSupport regulatory filings (IND/CTA/IMPD), act as SME during… more
- Insmed Incorporated (NJ)
- …Vault, ensuring compliance with document management standards, version control, and audit readiness.Coordinate the intake, formatting, and QC of regulatory documents ... regulatory archives.Partner with cross-functional teams (Regulatory Affairs, CMC, Clinical, Quality ) to facilitate document authoring, review, approval, and publishing… more
- Heritage Bank (Portland, OR)
- …Role at a Glance: Participates in the evaluation of the bank's asset quality , assessing adherence with lending and portfolio policy, loan approvals, and evaluating ... and supporting documentation for loan reviews. Prepares reports summarizing portfolio quality and risk issues with recommended corrective action. Participates in the… more
- USAA (Plano, TX)
- …mitigating risks, as well as ensuring compliance with relevant regulations and internal policies. Promotes risk-awareness and the overall effectiveness of risk and ... with Compliance and Risk Management, as well as Business Operations, IT, Audit Services, and Regulators to support risk and compliance-based initiatives. Responsible… more
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