- ARUNDEL MACHINE (Emerson, NJ)
- …regulations, prepare submissions and maintain regulatory databases + Adhere strictly to all CGMP , FDA 21 CFR820, ISO 13485, EU MDR and company procedures to ensure ... the quality and integrity of the products and safety of the workplace + Keep Quality area organized and clean + Keep stock of Quality materials such as tip protectors, test materials, etc. + Conduct training on receiving and inspections and orientation for new… more
- Merck (Rahway, NJ)
- …(OSD) manufacturing & development experience. + Familiarity with Quality, Regulatory, cGMP , Safety & Environmental Policies and Procedures + Strong technical writing ... skills to prepare Standard Operating Procedures (SOP) and cGXP documents + Exceptional organizational and analytical abilities with a keen eye for detail + Strong computer skills with preference for SAP experience + Strong communication and interpersonal… more
- Bristol Myers Squibb (Summit, NJ)
- …and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements **Knowledge & Skills:** + Demonstrated expertise in Process ... Automation Systems, specifically DeltaV, and data collection (ie, OSI PI). + Expert understanding of S88, S95 and batch processing operations required. + Understanding of engineering documentation such as P&IDs, FS/SCRs, process flow diagrams, and standard… more
- Astrix Technology (Ocean County, NJ)
- …gowning and cleanroom procedures and comply with 21 CFR Part 11 and cGMP requirements. **Qualifications** + High school diploma or equivalent required. + 3+ years ... of relevant mechanical or maintenance experience; experience in aseptic or pharmaceutical packaging preferred. + Strong troubleshooting, teamwork, and communication skills.This job description is a complete list of all desired skills, but not all are required.… more
- Merck (Rahway, NJ)
- …and supplier assessments + Remain informed of current Good Manufacturing Practices, cGMP , and Good Distribution Practices, cGDP, and requirements and industry trends ... as described in worldwide regulations and industry standards **Minimum Education Requirements and Experience:** + Bachelor of Science (BS) in packaging, mechanical, chemical, biochemical engineering, pharmaceutical science or chemistry or related fields with… more
- Insight Global (Morris Plains, NJ)
- …Planning, Technical Operations, etc. as well as the external manufacturer -Apply cGMP regulations and other FDA and international requirements to all aspects of ... the position. -Provide on-site support as needed on request of the team lead We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal… more
- Merck (Rahway, NJ)
- …Engage and participate in various internal and external current Good Manufacturing Practice ( cGMP ) audits or inspections. + Represent the GMP functional area on a ... working group team. **Education Minimum Requirements:** Minimum 5 years relevant industry experience for applicants with a Bachelor of Science degree, or at least 2 years of relevant industry experience for applicants with a Master of Science degree in… more
- Bristol Myers Squibb (Summit, NJ)
- …with blood derived components. **Knowledge & Skills:** + Knowledge of cGMP /FDA regulated industry. + Basic mathematical skills. + General understanding of ... cGMPs. + Technical writing capability. + Proficient in MS Office applications. + Inventory control and/or management. + Background to include an understanding of biology, chemistry, medical or clinical practices. **Basic Requirements:** + Bachelor's degree… more
- J&J Family of Companies (Raritan, NJ)
- …of the apheresis and cryopreservation processes is critical + Excellent knowledge of cGMP and GTP is required + Project Management skills and the ability to ... interface cross-functionally with other expertise areas including clinical and operational personnel are required + Understanding of drug development and submission requirements is required + Manufacturing and logistics understanding/experience is preferred +… more
- Merck (Rahway, NJ)
- …and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance and operational excellence in the laboratories, and for maintaining ... a state of inspection readiness at all times. The Director should be well engaged with regulatory and industry trends and have thorough working knowledge of GMPs, ICH, and relevant FDA guidelines. In addition, the Director will effectively partner with SMAR&D… more