- Bausch Health (Bridgewater, NJ)
- …our collective progress and impact. The Principal Engineer is responsible for managing the change control process . This role ensures that all changes to ... quality, compliance, and operational efficiency. Responsibilities: + Develop, implement, and maintain the change control process in compliance with FDA, EU… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …and reviewing CV sample analysis + Authoring CV method/validation reports and performing change control associated with the method revisions + Investigate and ... clinical studies. Our team is involved at the earliest stages of Pharmaceutical and Biopharmaceutical product development th rough the successful commercial launch.… more
- Merck (Rahway, NJ)
- …**Director, Oral Formulation Sciences Job Description:** Our company's Pharmaceutical Sciences and Clinical Supply (PSCS) organization translates molecules ... by designing, developing, and scaling-up the formulation, device, and manufacturing process . Driving drug product design from the benchtop to current Good… more
- Merck (Rahway, NJ)
- …This role supports the digital enhancements of quality systems, such as document control , deviation management, change control and quality risk management ... Training Programs, GMP Auditing, Interpersonal Relationships, IS Audit, Management Process , Manufacturing Processes, Manufacturing Quality Control , Process… more
- Nestle (Bridgewater, NJ)
- …for enterprise GxP IT systems, collaborating with business partners, to ensure effective change control , testing, validation, and communication. + Act as a ... technology solutions, and guide them through the IT governance process . By doing so, you will drive the planning,...and GAMP 5, CSA, Data Integrity. + Experience managing change control processes. + Must possess excellent… more
- Bristol Myers Squibb (Summit, NJ)
- …for the implementation of CAPAs prior to due date. + Participates in CAPA, Change Control , Capital meetings and defines, agrees, or owns CAPAs, Change ... for the IQ/OQ/PQ, UAT Testing, and other equipment or process enhancements. **Safety** + Takes personal responsibility to work...responsible to participate in the weekly Deviation, CAPA, and Change Control meetings to provide status updates… more
- Teva Pharmaceuticals (Edison, NJ)
- …be expected to act as a project manager for smaller equipment as well as process change projects. **How you'll spend your day** **Essential Duties / Functions** ... setting. + In depth knowledge of qualification requirements for pharmaceutical operations including packaging, utilities, CSV, automated control … more
- Eurofins (North Brunswick Township, NJ)
- …* Update procedures for improvement to methods. * Assist with OOS, NI, CAPA, and Change Control processes in response to Laboratory issues. * Other duties as ... network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization… more
- Sanofi Group (Ridgefield, NJ)
- …Space, Hazmat and Electrical Safety programs. + Experience reading and interpreting Process and Instrumentation Diagrams (P&IDs) and control schematics. + Have ... and bring hope to patients and their families. The Process Utilities department is dedicated to the uptime and...3 - 5 years experience working in a cGMP pharmaceutical manufacturing environment or other regulated environment. + 3… more
- Bristol Myers Squibb (Warren, NJ)
- …and Business Owners, coordinate equipment installation and asset induction. + Own project change controls and project validation master plans. + Owns change ... Responsibilities** + Understand new technologies, introduced to the Manufacturing and Quality Control areas, and serves as the first line of support during testing… more
- Eurofins (North Brunswick Township, NJ)
- …Part 820, ISO 17025, USP, and GxP. + Hands-on experience with CAPA, change control , quality events, and validation documentation (IQ/OQ/PQ). + Strong ... to senior leadership. Additionally, candidates will identify CAPAs, Deviations, Investigations, Change Controls, Process Improvements, and Root Cause Analysis.… more
- Merck (Rahway, NJ)
- …Management, Data Analytics, Driving Continuous Improvement, Global Sourcing Strategies, Inventory Control Management, Management Process , Managing Change ... units and regions. + **Strategy Development/Implementation:** Utilizes Sourcing Management Process and other tools and techniques to create breakthrough strategies… more
- Merck (Rahway, NJ)
- …Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ). . **Supply Chain Management:** Manage coordination ... molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical , Biologic, and Vaccine Products. Our team works with a "Safety… more
- Astrix Technology (New Brunswick, NJ)
- …and other relevant methods. + Assist in the creation, review, and closure of Change Control records. + Conduct quality testing, review QC data, and prepare ... **QMS Investigator** Quality Control Middlesex County, NJ, US Pay Rate Low:...statistical analysis tools to drive root cause identification and process improvement. + Initiate and investigate OOS, OOT, and… more
- Sanofi Group (Morristown, NJ)
- …scope and objectives. . Solid knowledge of the clinical trial development process and understanding of relevant and current regulatory guidelines, Good Clinical ... Leadership in driving cultural and structural shifts, shaping company standards in change management excellence **Global Study Data Leader:** + Contributes to the… more
- Lilly (Branchburg, NJ)
- …reduction, method optimization, and new method development. + Local and Global Method Change Control Ownership. + Oversight of reference standard evaluations per ... greatest health challenges. The Analytical Technical Steward in API (Active Pharmaceutical Ingredient) External Manufacturing Quality Control is a technical… more
- Bristol Myers Squibb (Summit, NJ)
- …disseminate results to project stakeholders and senior management. + Support the change initiatives and the implementation of process improvement initiatives. + ... + 9+ years of manufacturing support, manufacturing engineering, or MS&T process engineering experience in the biotechnology/ pharmaceutical industry. + 2+… more
- Lilly (Branchburg, NJ)
- …technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also ... Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and… more
- Aston Carter (Newark, NJ)
- …of contact and subject matter expert for all materials handling, inventory control , and GMP warehouse operations, independently receive, inspect, and verify incoming ... point of contact and subject matter expert for all materials handling, inventory control , and GMP warehouse operations at the Newark site. + Independently receive,… more
- Publicis Groupe (New York, NY)
- …vendor engagement + Execution: Handles production of engagements from award to completion + Change process : Handles change request process , identifying ... Quality Control : Ensures team adherence to QC plan + Process improvement: Proactively finds opportunities to adjust processes for efficiencies. Identifies… more