- Merck & Co. (Rahway, NJ)
- …conducting system hazard analyses and Failure Modes and Effects Analysis (FMEA), implementing risk control measures, and performing overall device risk ... internal and external sites ensuring proper translation and implementation of risk control measures.Analyze information from post-market surveillance, clinical… more
- Repligen (Waltham, MA)
- …ensure "controls by design."Maintain ITGC narratives, process flows, and risk / control matrices.Identify and drive process improvements, automation opportunities, ... digital systems. This role drives the ITGC audit program, advises on risk mitigation strategies, and partners closely with Internal Audit, IT, Financial Reporting,… more
- Merck & Co. (Rahway, NJ)
- …responsible for leading and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This ... the execution of device development strategies and drive continuous improvement in design control and risk management processes. This individual will be expected… more
- Insmed Incorporated (NJ)
- …We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will ... requirements while maintaining operational excellence. The Executive Director, Cybersecurity & Risk Management plays a critical leadership role in safeguarding that… more
- Cipla (Central Islip, NY)
- …analytical techniques (HPLC, GC, UV-Vis etc.) and familiarity with quality control procedures. Responsible for performing routine analytical testing of raw material, ... Understanding of regulatory compliance, quality management systems and document control processes, and the ability to collaborate cross-functionally and communicate… more
- Cipla (Fall River, MA)
- …proper documentation of all quality systems and records. Oversee document control processes, ensuring that SOPs (Standard Operating Procedures), work instructions, ... remains compliant with all regulatory requirements (eg, FDA, ICH, EMA). Support risk assessments and help mitigate any potential quality risks to product safety… more
- Merck & Co. (Rahway, NJ)
- …experiments to create effective shipping solutions to maintain temperature control and physical protection.Collaborate with cross-functional teams to evaluate ... protection systems, particularly in qualification of shipping systems (temperature control and protection from shock, vibration, and compression).Strong problem-solving… more
- Merck & Co. (Rahway, NJ)
- …as system development lifecycle (SDLC), assessments of data integrity, privacy, risk , and other aspects necessary for GxP useImplement automation solutions, ... and visualization capabilitiesDevelop and complete appropriate system validation, Change Control and testing documentation, ensuring compliance with all requirements.Support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …scope includes working on Quality related sub-teams such as change control sub-teams and investigational sub-teams. The material/ raw material scope includes ... validation, data analytics (including CPV), quality compliance (including change control and investigations), and material/ raw material sub-teams to support… more
- Cipla (Fall River, MA)
- …management evaluation of performance trends. Owns quality records (change control , CAPA's, deviations) and delivers to established timelines. Autonomously leads ... deviations. Develop, implement and assess solutions for complex problems. Anticipates risk and builds contingencies to help mitigate impact. Reviews document for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the interdependent deliverables for MES and/or digital projects and ensures that quality, risk , cost, time are managed within the overall approved plan to drive ... criteria for the project.Develops options and solutions to complex project risk problems, providing guidance to leadership including trade-off and implications… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …purchase order generation and invoicing.Work with financial teams to plan, track and control CMO budget.Work with integrated business planning team (IBP) and Vein to ... Quality and the CMO teams to collaboratively drive the deliverables and timelines.Conduct risk and gap analysis, maintain risk registry and develop mitigation… more
- Merck & Co. (Rahway, NJ)
- …and compliance.Schedule Adherence: Understands schedule adherence impact and communicates risk .- Maintains a continuous improvement mindset and implements initiates ... to increase efficiency or reduce risk to schedule adherence.Compliance: Identifies and addresses compliance, environmental, safety, and process deviations as… more
- ValSource, Inc. (Rahway, NJ)
- …projects simultaneously. Strong understanding of EPCMV, Quality by Design and risk -and science-based approaches for compliance are desired. Experience with system ... and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis...scientific event which helps companies design, perform and better control manufacturing processes throughout all stages of the operations… more
- Cipla (Fall River, MA)
- …deviations. Develop, implement and assess solutions for complex problems. Anticipates risk and builds contingencies to help mitigate impact. Reviews document for ... and regulatory auditors. Performs weekly quality reviews of Master Control database by assuring new documents have been entered...a plus. Knowledge and handling of deviation, CAPA, change control , FMECA and training. Knowledge and handling of SAP… more
- Bayer (Whitestown, IN)
- …to Bayer s Health, Safety, Environment (HSE) and Quality Assurance/Quality Control (QA/QC) standards (eg general shop floor/machine safety and operating procedures). ... company car, your driving record must meet guidelines based on the company s Risk Screening for Hiring Drivers MVR will be reviewed as part of pre-employment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …budgeting, forecasting, and cost tracking.Ensure compliance with internal control processes, GxP standards, and regulatory requirements.Maintain SAP/Ariba or ... and implement opportunities for cost savings, process improvements, and risk mitigation.Directly support internal audits, regulatory inspections, and procurement-related… more
- Merck & Co. (Rahway, NJ)
- …development and chemistryHigh-throughput experimentation, automation, and process control .Knowledge of microbial fermentationCell culture predictive modeling (omics ... Line Engineering, Clinical Judgment, Communication, Flux Analysis, Human Health Risk Assessment, Innovative Thinking, Interpersonal Relationships, Mammalian Cell Culture,… more
- ValSource, Inc. (Durham, NC)
- …are expected to include but are not limited to: Collaboratively conduct Risk Assessments and Impact assessments, and establish system boundaries Generation, Review, ... project budgets, review of invoices, and any other duties as required to control financial and execution related aspects of project. Project Leaders/Managers may be… more
- Merck & Co. (Rahway, NJ)
- …manipulate electronic healthcare databases to discover disease prevalence and risk factors, describe drug utilization patterns and disease progression, answer ... CPT, NDC, LOINC; data standards like Common Data Model (CDM); version control toolsFamiliarity with the fields of Outcomes Research and Epidemiology including… more
