- 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
- Sanofi Group (Pearl River, NY)
- … control (experience with additional aspects is desired): * pharmaceutical microbiology, * aseptic processing and environmental monitoring, * clean room ... **Job Title:** Sterility Assurance Lead - Contamination Control **Location:** Pearl River, NY **About the Job**...are some key points: + **Support for recombinant manufacturing process ** : You'll be working closely with the Head… more
- Actalent (Parsippany Troy Hills, NJ)
- Job Title: Document Control Specialist Job Description We are seeking a meticulous and highly organized Document Control Specialist to join our team. In this ... requirements. Document Systems & Compliance + Manage the publishing and release process of controlled documents in DMS to support operational and regulatory… 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)
- …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
- Merck (Rahway, NJ)
- …(GMP), Inventory Control Management, Logistics Coordination, Management Process , Master Batch Records, Operational Efficiency, Pharmaceutical Management, ... within clinical supply. + Identify opportunities for innovation and process improvement, supporting necessary changes to enhance operational effectiveness.… 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
- 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
- Danaher Corporation (New York, NY)
- …role, you will have the opportunity to: + Act as a subject matter expert for Change Management/ Change Control process supporting other QMS functions such ... is responsible for various aspects of the QMS, including change control , risk management, non-conformances, CAPAs, complaints,...as Nonconformance and CAPA process , Complaint and Field Action process as… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …quality related functions such as batch disposition, quality incident investigations, change control , procedural review and GMP/procedural training to ensure ... studies resulting in a BS, in chemistry, pharmacy or biology or a related pharmaceutical science, with 7-9 years of relevant experience within the pharmaceutical … 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
- 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
- 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
- ThermoFisher Scientific (New Brunswick, NJ)
- …that stability activities are completed per site and brand timelines. + Perform change control impact assessments and document the stability assessment in ... communication skills in presenting stability strategy to technical teams and in change control and investigations management system. Ability to work… 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