- Kelly Services (Somerset, NJ)
- …identify trends and opportunities for process improvement. + Ensure systems meet GMP , GLP, and other applicable regulatory standards. + Provide end-user support and ... and compliance documentation (IQ/OQ/PQ). **Knowledge/Skills:** + Strong understanding of GMP /GLP regulations and quality system requirements. + Hands-on experience… more
- Hovione (East Windsor, NJ)
- …equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes ... of practice. - Execute professional activities in compliance with GMP , internal and external requirements as well as...plants or Pharmaceutical industry - Training and experience of GMP and HSE practices (mandatory) - Advanced knowledge of… more
- Integra LifeSciences (Plainsboro, NJ)
- …+ Author or revise Standard Operating Procedures (SOPs). + Participates in FDA inspections, ISO certifications, surveillance audits, and customer audits. + Interpret ... procedures, and other data to determine product or material acceptance. + Maintain GMP documentation and adhere to Good Documentation Practices. + Read and interpret… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …service providers. Support and participate at regulatory audits, such as state inspections, FDA audits, QA audits, etc. + Monitor the new regulation and industry ... standard such as GMP in terms of US supply chain and secure...regulations as they pertain to supply chain activities (eg, GMP , US Serialization, Logistics). + Experience working with CMO,… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …to join our team. This position will be part of the Analytical Regulated Testing GMP team at BMS New Brunswick New Jersey within the Analytical Strategy & Operations ... of methods. + Ensure compliance with regulatory requirements (eg, FDA , EMA) and industry standards (eg, cGMP, ICH) related...regulatory requirements and guidelines related to cleaning verification (eg, FDA , EMA, ICH Q7, Q9, Q10). + Ability to… more
- Integra LifeSciences (Plainsboro, NJ)
- …perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other ... in science is preferred. + 3-7 years of relevant GMP /GLP experience specific to incoming, line clearance, in-process, and...Control, preferred. + Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP. + Knowledgeable in Microsoft Office… more
- Integra LifeSciences (Plainsboro, NJ)
- …perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other ... + High School Diploma. + 1-2 years of relevant GMP /GLP experience specific to incoming, line clearance, in-process, and...interpersonal skills. + Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP preferred. + Knowledgeable in Microsoft… more
- Integra LifeSciences (Plainsboro, NJ)
- …perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other ... * High School Diploma. * 1-2 years of relevant GMP /GLP experience specific to incoming, line clearance, in-process, and...interpersonal skills. * Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP preferred. * Knowledgeable in Microsoft… more
- Integra LifeSciences (Plainsboro, NJ)
- …perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other ... + Minimum HS Diploma + 0+ years of relevant GMP /GLP experience specific to incoming, line clearance, in-process, and...Control, preferred. + Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP. + Knowledgeable in Microsoft Office… more
- Bristol Myers Squibb (Summit, NJ)
- …or equivalent experience. + Minimum 5 years of experience in FDA -regulated industry. **Working Conditions:** + Occasional stooping, bending, stretching, pushing, ... and pulling. + Primarily an office environment. Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety… more