- Amneal Pharmaceuticals (Piscataway, NJ)
- …to ensure operational excellence, equipment reliability, and compliance with cGMP standards. Essential Functions: + Develop, implement, and optimize preventive ... and corrective maintenance programs to maximize equipment uptime and reliability. + Diagnose and resolve complex mechanical, electrical, pneumatic, hydraulic, and automation-related failures independently. + Lead the maintenance, troubleshooting, and repair of… more
- BeOne Medicines (Pennington, NJ)
- …Cabinets, Plate Washers, and Microplate Readers, etc. + Knowledgeable with USP/EP and cGMP /EU GMP regulations. + Direct experience in a GMP quality control lab is ... a must. + Familiar with instrument and equipment validation. + Expert knowledge of quality control principles, practices, and standards for the biopharmaceutical industry. + Impressive, demonstrable track record and skills/experience gained within a similar… more
- Bristol Myers Squibb (Summit, NJ)
- …or Black belt is preferred but not required + Expert understanding of cGMP regulations and/or business and documentation processes. + Expert in root cause analysis, ... CAPA and risk mitigation + Proficient in project and portfolio management skills If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will… more
- Bristol Myers Squibb (Summit, NJ)
- …such as Python, R, etc., is a plus. + Expert understanding of cGMP regulations and/or business and documentation processes. + Highly proficient in technical writing ... and technical presentations, contributing to broader external and internal scientific community as appropriate. Experience in generating formal reports and articles for publication and in technical presentation + Proficient in project and portfolio management… more
- Bristol Myers Squibb (Summit, NJ)
- …completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. + High problem-solving ability/mentality, critical thinking, technically ... adept and logical. + Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs. + Ability to work in a fast-paced team environment, action oriented, highly organized to meet… more
- Integra LifeSciences (Plainsboro, NJ)
- …preferred. + Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP . + Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred. ... + Ability to define problems, collect data, establish facts and draw valid conclusions + Ability to work effectively in a cross functional environment + Ability to integrate quality objectives across multiple functions + Attention to detail, strong time… more
- Integra LifeSciences (Plainsboro, NJ)
- …electrical repair and diagnostic tools/ instruments skillfully. + Complete all cGMP documentation associated with calibration and maintenance tasks. + Review ... calibration SOPs for accuracy during routine calibration or when a new instrument is introduced into the calibration database. Create or revise the SOPs as needed + Willingness to perform other related tasks. + Able to work with minimal supervision. + Able to… more
- System One (Cranbury, NJ)
- …from various locations throughout the company, including current Good Manufacturing Practices ( cGMP ) area + Sweeps and cleans floors as required and maintain other ... areas as needed in a neat and orderly fashion + Keeps manufacturing , lab, cafeteria and office areas clean at all times + Empties plastic bags from trash receptacles, tie and transport + May be required to ensure adequate supplies are in stock + May transport… more
- Lilly (Branchburg, NJ)
- …industry. + Must maintain excellent working knowledge of pharmaceutical regulations (eg cGMP 's, 21 CFR Part 11, Computers Systems FDA) and other applicable ... regulations (eg Privacy, OSHA, etc.) related to laboratory and/or manufacturing environment and system applications. + 3+ years basic understanding of databases (Oracle, SQL, etc.) and operating systems (Windows, etc.). **Additional Skills/Preferences:** +… more
- ThermoFisher Scientific (Teterboro, NJ)
- …experience for the aseptic production of sterile products is preferred + cGMP experience preferred + Gown certified **Knowledge, Skills, Abilities** The physical ... demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The majority of the work activities are performed while standing. + Demonstrate requisite skills and… more