- 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
- Merck (Rahway, NJ)
- …Quality Control , Medical Supply Management, Medicinal Chemistry, Pharmaceutical Process Development, Pharmaceutical Sciences, Phytochemistry, ... Process Control Automation, Process Optimization, Process Simulation, Product Formulation, Safety Compliance, Standard Operating Procedure (SOP)… 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
- 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
- Merck (Rahway, NJ)
- …maintenance support to facilities & utilities for Rahway, New Jersey pharmaceutical research campus and headquarters for our Company's Support day-to-day ... to be able to start, stop, seek status, or change conditions on HVAC systems. + Interpret equipment blueprints,...units, chillers, and associated equipment. + Knowledges of program control wires and other related electrical equipment. + Wire… 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
- Aston Carter (New York, NY)
- …a crucial role in sourcing, screening, and hiring top talent for Quality Control (QC) and Quality Assurance (QA) roles within our organization. You will collaborate ... system (ATS). + Ensure a positive candidate experience throughout the recruitment process . + Stay informed about industry trends and regulatory requirements in … more
- WuXi AppTec (Cranbury, NJ)
- …years of pharmaceutical or CRO/CMO industry experience, preferably in API process R&D and manufacturing and/or Drug Product R&D and manufacturing. + Prior ... and small molecule drug development. + Minimum of 5 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP… 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
- Merck (Rahway, NJ)
- …simultaneously, and to meet deliverables and timelines. **Preferred:** + Experience in pharmaceutical or related industry in quality control , quality assurance, ... of clinical supplies including batch records, deviation and/or out-of-specification approval, change management approval, etc. + Support the Quality Program Lead on… more
- Endo International (Cranbury, NJ)
- …+ Review and update open purchased order report. + Convert planned orders to process orders; release and update existing process orders as needed. + Supports ... times, inspection lead times, etc. as needed. + Maintain control of material changes (new or revised) to assure...Review Accounts Payable (AP) issues. + Manage changes and change controls related to suppliers and purchasing. + Assist… 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
- 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
- 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
- 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
- embecta (Parsippany, NJ)
- …collaboration with R&D, Operations and Supply Chain for embecta product. + Improve the change control process by streamlining procedures and processes to ... analysis tools and methodologies such as Design of Experiments (DOE), Statistical Process Control (SPC), and Measurement Systems Analysis (MSA). + Demonstrated… more