- Grifols Shared Services North America, Inc (Trenton, NJ)
- …teams of needed updates/changes **Additional responsibilities:** + Represent R&D Compliance in professional and industry organizations. **Knowledge, skills, & ... abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding...to evaluate complex issues and meet deadlines to ensure compliance , as well as business timelines to accomplish company… more
- Sumitomo Pharma (Trenton, NJ)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... (written, verbal, electronic, etc.) that an employee encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable… more
- Merck (Rahway, NJ)
- …regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies ( FDA , EMA, JNDA, TGA). + **Leadership:** Establish, manage and support CMC ... teams to achieve program goals as One Team. Champion compliance and safety; promote a culture of diversity, inclusion,...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los… more
- Teva Pharmaceuticals (Edison, NJ)
- …and participate in factory acceptance testing and commissioning support, ensuring compliance with company and regulatory standards. + Collaborate with Engineering, ... for Engineering Studies to establish robust equipment operating parameters. + Ensure compliance with the Site Validation Master Plan and Validation Project Plans,… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …products using USP/NF, EP, in-house test methods and standard protocols, maintaining full compliance with all applicable US FDA - cGMP regulations and internal ... to technical problem solving and troubleshooting as needed. + Contribute towards optimizing laboratory operations to increase efficiency and GMP compliance . more
- Promotion In Motion (Somerset, NJ)
- …+ Approve or reject reworked items. + Conduct GMP inspections to ensure compliance . + Monitor, verify and document Critical Control Points (CCP) for Food Safety. ... inspection and clearance. + Conduct GMP inspections to ensure compliance . + Monitor and verify Critical Control Points (CCP)...Certificate of Analysis is provided by the Supplier and FDA documents have been released for imported products. +… more
- Terumo Medical Corporation (Somerset, NJ)
- …with Customer Operations on stock availability for Domestic business and Global Trade Compliance for Import and Export business. + Act as a liaison between ... for IBP/APO experience or supply planning functionality + Perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with … more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Leads all aspects of a team in SM business unit, guiding compliance , product development, and clinical validation. **Key Responsibilities:** + Strategic Medical ... educational, promotional, and advertising materials to ensure clinical accuracy and compliance with regulatory standards. + Work collaboratively with R&D, Marketing,… more
- System One (Park Ridge, NJ)
- …leading high-impact sterilization programs, and ensuring full regulatory compliance across the product lifecycle-from development through commercialization. This ... others while setting long-term technical strategies aligned with corporate innovation and compliance goals. The Principal Scientist must demonstrate a high level of… more
- Sokol Materials & Services (Skillman, NJ)
- …Strong understanding of validation principles, methodologies, and regulatory requirements, including FDA , EMA, and ICH guidelines. Knowledge, Skills & Abilities: + ... risk assessments and impact analyses to ensure validation accuracy and compliance . * Collaborate with cross-functional teams to coordinate and manage CQV… more