- J&J Family of Companies (Raritan, NJ)
- …Johnson is recruiting for an **Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager ** , located in either **Horsham, PA; Raritan, NJ; ... The Enterprise Quality R&D Clinical Computer System Validation (CSV) Manager is responsible for guiding...and/or CSV for R&D systems + Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part… more
- Integra LifeSciences (Princeton, NJ)
- …and set new standards of care. Under direct supervision of Director, Quality Reliability Microbiology, the Sr. Manager , Microbiology Reliability - Tissue ... technical employees is preferred. Responsibilities associated with this Sr. Manager , Microbiology Reliability - Tissue Technology (TT) are directly associated… more
- Cardinal Health (East Rutherford, NJ)
- …and reports metrics related products and processes as deemed necessary by the Regional Quality Manager RQM. + Ensures the site manufactures products to meet the ... quality , analytical metrics and / or statistics, trending, quality planning, validation , CAPA and problem solving....requirements of 21 CFR 212 ( CGMP ) + Handles and ensures quality of… more
- BeOne Medicines (Pennington, NJ)
- …and cGMP /EU GMP regulations. + Familiar with instrument and equipment validation . + Expert knowledge of quality control principles, practices and standards ... **General Description:** Manages all Quality Control (QC) Physicochemistry laboratory activities to support...the Physicochemistry laboratory. This position reports to the Senior Manager QC and is located full time at the… more
- J&J Family of Companies (Titusville, NJ)
- …Strategies, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation , Relationship Building, Risk Management, ... for interactions with External partners. + Investigate customer product quality complaints. + Apply cGMP regulations and...Abilities** **:** + 10+ years as a seasoned people manager with proven track record of leading large global… more
- System One (Pennington, NJ)
- …opportunities for impact and visibility Must-Have Qualifications + Deep knowledge of Quality Management Systems (QMS), cGMP , data integrity, and regulatory ... Job Title: QC Compliance Manager - Biologics / Biosimilars Location: Greater Princeton,...compliance frameworks. + Work with advanced biologics platforms and global- quality operations. + Thrive in a dynamic, startup-like environment… more
- BeOne Medicines (Pennington, NJ)
- …preventive actions (CAPAs). + Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation. ... with Waters Empower Chromatography Data System. + Working knowledge with USP/EP and cGMP /EU GMP regulations. + Familiar with instrument and equipment validation .… more
- BeOne Medicines (Pennington, NJ)
- …quality control lab is a must. + Familiar with instrument and equipment validation . + Expert knowledge of quality control principles, practices, and standards ... laboratory through late phase activities. + Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global … more
- BeOne Medicines (Pennington, NJ)
- **General Description:** _The Senior_ _Project Manager requires rich technical experience in construction project management for pharmaceutical production facility ... of capital projects at BeOne sites on time, on budget, and with quality . This position requires close collaboration with cross-functional teams (eg, R&D, WPS, GTS,… more
- Hovione (East Windsor, NJ)
- …pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. ... on time and within budget) and in compliance with cGMP , HSE regulations and internal policies and procedures. -...procedures, mass balance sheets, bill of materials, cost proposals, validation plans and validation reports and other… more