- Formation Bio (New York, NY)
- …the product development lifecycle. Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and ... and sites, providing support during health authority inspections, and offering guidance on quality issues . Ensuring vendors adhere to relevant quality … more
- Capital One (New York, NY)
- …audits of controls in cloud-based environments 4+ years of experience in risk and data management 4+ years of experience performing data analysis in ... microservices), information security (application security, network security, cyber security, data protection), information systems risk management , information… more
- Capital One (New York, NY)
- …XSLT. Provide technical expertise on Workday Studio technologies, security, troubleshooting system issues , data analysis, vendor management and coordination ... designed, elegantly coded and effectively tuned for platform performance and quality Basic Qualifications: High School Diploma, GED, or equivalent certification At… more
- Merck & Co. (Rahway, NJ)
- …Compliance (IC), and Policy, Licensing and Evaluation (PEL).Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements ... GMP Auditing, GMP Compliance, GMP Operations, Good Manufacturing Practices (GMP), Inspection Readiness, Quality Auditing, Quality Management , Quality … more
- Merck & Co. (Rahway, NJ)
- …Content Management , Content Management Systems (CMS), Cross-Cultural Awareness, Data Management , Data Quality Assessments, Documentation Review, ... questions and issues related to submission content management , quality and standards complianceEngage across functional...process requirementsDevelop and evaluate metrics as part of a data quality monitoring plan to determine where… more
- Merck & Co. (Rahway, NJ)
- …our patients, partners, and colleagues.As a Technical Product Manager for the Compliance, Risk, Quality , & Vendor Management product you will spend a lot of time ... across the organization. Candidate will be accountable for the entire Compliance, Risk, Quality , & Vendor Management product from the prioritization and roadmap… more
- InterSources, Inc. (New York, NY)
- …policies, and procedures. ssist with identification, documentation and management of any data quality , integrity and availability issues . Other duties as ... in Excel (eg, advanced formulas, macros, etc.). Expertise in relational database management systems, SQL, data modeling. bility to translate complex business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming ... reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.Oversees the execution of external… more
- TYLin (New York, NY)
- … data needs and develop tailored solutions. + Validate and reconcile data , implement quality checks, and establish security protocols including access ... and ongoing technical support. + Monitor and maintain BI infrastructure, troubleshoot data pipeline issues , and ensure optimal system performance. + Stay… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the drug development process.- Collaborates within the function and cross-functionally to resolve issues pertaining to data management in clinical trials and ... to ensure data quality /integrity and regulatory compliance- Ensures that Data Management Plans are consistent and regulatory compliant across studies and… more
- FreshRealm (Linden, NJ)
- …hour) + Document all audits in Quality Tool Suite + Notify Specialist and Quality Auditor of any issues + Attend monthly refresher trainings with Quality ... **General Job Description** FreshRealm looking for a Quality Control Technician Level 1 in our Fulfillment...norms, assumptions, and best practices Experiment and take calculated, data -driven risks + **OBJECTIVITY** : Utilize data … more
- ValSource, Inc. (Rahway, NJ)
- …Part 11 compliance and latest industry expectations for data integrity. Project Management experience in managing scope, cost, schedule, quality , and risk is ... Requirements Minimum of 7 years’ experience with increasing responsibility in validation/ quality service and project management of life sciences, biotech… more
- Merck & Co. (Rahway, NJ)
- …the team alignment with functional objectives.Ability to communicate program progress, issues , and mitigation plans to the senior management .Innovative mind-set ... and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The… more
- Merck & Co. (Rahway, NJ)
- … Process, Preparation of Financial Reports, Procurement, Project Human Resource Management , Project Management , Quality Standards, Report Writing ... will be expected to lead small teams of auditors audits with limited management supervision in addition to actively performing audit work.Under the direction of the… more
- Merck & Co. (Rahway, NJ)
- …Development, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Research Management , Clinical Studies, Clinical Testing, Clinical Trials, Data ... Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new… more
- Merck & Co. (Rahway, NJ)
- …excellence in support of the portfolio of work, including interrogation of the data / science through technical reviews and exploring alternative ways to view and ... introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk mitigation, and risk… more
- Jobleads-US (New York, NY)
- …research and development, to deliver impactful solutions in talent management , employee engagement and relations, compensation, and organizational development. The ... ideal candidate will be a data -driven problem solver with strong analytical, communication, and influencing skills, capable of building effective relationships with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contract quality and adherence PV Regulatory Intelligence: Oversees the Management of PV Regulatory Intelligence and dissemination across CSPV stakeholders for ... the key DSI contact for PV service providers to address, escalate issues requiring attention or resolution, and proactively drive operational excellence and… more
- Merck & Co. (Rahway, NJ)
- …teams. Problem Solving: -Remove roadblocks, resolve conflicts, and escalate issues when needed. Communication: -Foster collaboration, ensure transparency, and engage ... governance bodies. - Excellent interpersonal and communication skills Project Management : -Drive project schedules, set clear priorities, and monitor performance… more
- FreshRealm (Linden, NJ)
- …organoleptic, and packaging integrity testing + Maintain records and forms from Quality Management System software **QUALIFICATIONS FOR THE JOB** **Skills and ... hourly check, GMP audit, internal audit, FSQA tickets, Customer issues and CAPAs. + Investigate quality and...norms, assumptions, and best practices Experiment and take calculated, data -driven risks + **OBJECTIVITY** : Utilize data … more
