- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …This role ensures continuous monitoring of product performance, safety, and regulatory compliance throughout the product lifecycle. The individual collaborates ... Team Members:** Provide expert guidance on technical principles, quality sciences, and regulatory compliance to develop junior team members. + **Solve Complex… more
- Lilly (Branchburg, NJ)
- …to organizational transformation and data analytics. + Ensure MES system is in compliance with industry-specific regulations, such as FDA guidelines and GMP ... processes and procedures are in place for all activities to meet quality and compliance standards. Experience with GMP regulations. + Must assist with the support of… more
- Integra LifeSciences (Princeton, NJ)
- …execute plans. + Deep knowledge of global sourcing, contract manufacturing, and regulatory compliance in medical devices. + Strong leadership, negotiation, and ... and compliance history. + Collaborate closely with R&D, Quality, Regulatory , Legal, and Operations to ensure alignment across product lifecycle phases and… more
- Ascendis Pharma (Princeton, NJ)
- … Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits. . ... Science for patient safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations and as appropriate, local… more
- Bristol Myers Squibb (Princeton, NJ)
- …liaison with CROs and external partners, managing study milestones, deliverables, and compliance with BMS quality systems and regulatory standards. ** ... for regulated bioanalytical studies and CDx development, ensuring high quality, compliance , and timely delivery of internal and outsourced projects. This role… more
- ManpowerGroup (Franklin Twp, NJ)
- …technical support to production units, outside vendors, and quality laboratories. + Ensure compliance with FDA and ISO guidelines, including SOPs, auditing, and ... finished goods. + Perform quality system activities to meet regulatory requirements. + Assist in quality investigations, reporting, and...with a strong emphasis on quality. + Knowledge of FDA and ISO compliance standards. + Experience… more
- Kedplasma (Cinnaminson, NJ)
- …procedure and plasma collection, including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + ... scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...needed. + Records any required documentation accurately and in compliance with company SOPs. + Maintains data integrity and… more
- Terumo Medical Corporation (Somerset, NJ)
- …Ongoing collaboration with medical, regulatory and legal partners to assure compliance with FDA regulations US laws and appropriate clinical representation ... + Demonstrate a commitment to patient safety and product quality by maintaining compliance with all TMC Quality Systems requirements. This includes but is not… more
- Integra LifeSciences (Plainsboro, NJ)
- …to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all assigned employees ... production schedules. All production is to be conducted in compliance with ISO 7 and ISO 5 Clean Rooms...costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. +… more
- Integra LifeSciences (Plainsboro, NJ)
- …to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all assigned employees ... production schedules. All production is to be conducted in compliance with ISO 7 Clean Rooms and with Good...costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. +… more