- Merck & Co. (Rahway, NJ)
- …Support: The analyst will create detailed process documentation, including workflows and data models. They will support project management by tracking tasks, ... Transformation, Informatica Metadata Manager, Management Process, Process Flow Documentation, Project Management, Regulatory Documents, SAP Master Data … more
- ValSource, Inc. (Rahway, NJ)
- …ValSource is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a ... ensuring compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead teams of… more
- Merck & Co. (Rahway, NJ)
- …with regulatory, company, and customer requirements. - Principal Responsibilities Lead /Support continuous improvement initiatives for design control and ... Develop actionable remediation plans and drive their execution through to closure. Lead /contribute to device development, design controls for the assigned… more
- Merck & Co. (Rahway, NJ)
- …operations, and qualification needs.Execute and develop appropriate system validation, change control , and testing documentation in partnership with project CQV ... is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway,...Calibration procedures, Training, and SOPs for all GxP automation systems. Lead integration of control systems with MES,… more
- Aequor (Vacaville, CA)
- …and regulatory inspections Works to meet schedules, timelines, deadlines Participate in and/or lead group and project teamwork; project and process ... OOT, OOE) and other laboratory support activities. In conjunction with Quality Control leadership, the QC Associate II works to meet departmental and organizational… more
- Merck & Co. (Durham, NC)
- …Company sites, Procurement, Raw Material & Component SuppliersDevelop effective data analytics methodologies, including statistical process control , deepening ... and/or automation changes. Managing on-time implementation and close-out to meet project , production and supply timelines. Lead aspects of regulatory inspections… more
- Merck & Co. (Rahway, NJ)
- …and management of the following automated systems;Programmable Logic ControllersSupervisory Control And Data Acquisition systemsDistributed Control ... Control , Mechanical Troubleshooting, Pharmaceutical Process Development, Process Control Automation, Process Optimization, Product Formulation, Project … more
- Merck & Co. (Rahway, NJ)
- …years) in pharmaceutical, biotechnology, or medical devices with proven success in Project management and team leadershipDemonstrated ability to lead and develop ... US and Switzerland, implementing a new operating model and ways of working. Lead a team of technical experts responsible for:Managing systems, equipment and processes… more
- Cipla (Fall River, MA)
- …operating conditions. Review of engineering records such as temperature and humidity data calibration and PM records, Pest control records and contractor ... Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab and follow detailed documentation procedures to deliver the… more
- Merck & Co. (Rahway, NJ)
- …years) in pharmaceutical, biotechnology, or medical devices with proven success in Project management and team leadershipDemonstrated ability to lead and develop ... US and Switzerland, implementing a new operating model and ways of working. Lead a team of technical experts responsible for:CSO Compliance OperationsCSO Integration… more
- AUROBINDO (Durham, NC)
- …healthier world to live in.Job OverviewThe QC Supervisor focused on the Quality Control Laboratory, offering project and task management along with technical ... based on business needs.Supervise Daily Operations: Oversee the quality control department's day-to-day operations.Responsible for Data Integrity compliance… more
- Aequor (Thousand Oaks, CA)
- …This engagement requires conformance with site policies, safety, quality, and data -integrity requirements. The successful candidate must model 's mission and the ... banks for cell-based potency assay methods in Process Development (PD) and Quality Control (QC), with a primary focus on adherent mammalian cell lines. Support… more
- Aptyx (Charlotte, NC)
- …Demonstrated ability to build prototypes, perform mechanical testing, and interpret performance data . Working knowledge of design controls , risk management, ISO ... throughout the full product lifecycle. Key Responsibilities Participate in or lead the design and development of complex steerable catheters including deflection… more
- Insmed Incorporated (San Diego, CA)
- …Manage and provide oversight on multiple projects simultaneously. Coordinate and lead validation activities with internal stakeholders and project team ... review and approval in Veeva etc. This role will participate in on site Change Control CAB meetings as the CSV lead . Who You Are: Position Requirements (Required… more
- TYLin (San Francisco, CA)
- …precious resources by finding more sustainable solutions. **Job Summary** We're seeking a Project Controls Specialist III (Cost Engineer) with cost and risk ... a large Capital Improvement Program (CIP). The ideal candidate has large program and project controls experience with proven success managing project costs,… more
- Insmed Incorporated (NJ)
- …management and remain in a validated state (eg SDLC, IT Change Control ) per associated SOPs, regulatory and security requirements. \tEnsure compliance and ... efficiency of validated systems through participating in release management, change control , periodic reviews, and audit trail reviews.What You'll Do: Develop… more
- Merck & Co. (Rahway, NJ)
- …can thrive.Responsibilities include but are not limited to:Partner with functional area project teams and subject matter experts to establish and implement the ... documentation of experiments for the adoption and development of innovative technologies. Lead the design and execution of bench scale process development experiments… more
- Cipla (Fall River, MA)
- …is responsible for the creation and revision of new and existing GMP, project handle, qualification & validation documents preparation and execution. In this role ... leads and manages projects to implement continuous improvement opportunities. Lead and/or support root cause investigations related to performance trends… more
- Merck & Co. (Rahway, NJ)
- …innovative-focused culture. Proactively identifying operational risks and implementing data -driven mitigation strategies to ensure strong operational performance. ... that allows for enhanced efficiency with required responsiveness/flexibility to project -specific needs. Primary Activities (including but not limited to): Provide… more
- Merck & Co. (Rahway, NJ)
- …of DCT deliverables including - robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust ... patients we serve. Problem Solving and Innovative Thinking:-- Gathers and analyzes data and effectively responds to new or complex situations, developing creative… more
