- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …Demonstrated knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; ... industry or international standards and ability to interpret and apply including FDA QSR, ISO 13485, MDSAP, and EU MDR/IVDR standards + Advanced knowledge… more
- Bristol Myers Squibb (Summit, NJ)
- …GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. + Advanced knowledge of ... **Basic Requirements:** + Bachelor's degree. + Minimum 2 years' experience in FDA -regulated industry. + 2 years of maintenance coordinating / planning experience,… more
- Sumitomo Pharma (Trenton, NJ)
- …programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
- Sumitomo Pharma (Trenton, NJ)
- …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- Merck (Rahway, NJ)
- …Campus. This role ensures HVAC systems comply with regulatory standards (eg, FDA , cGMP), maintain optimal environmental conditions for product quality, and support ... candidate will have strong technical expertise in HVAC design, maintenance, and validation within a highly regulated environment, combined with leadership skills to… more
- Merck (Rahway, NJ)
- …tech transfer to internal and external manufacturing sites, process validation , second generation process development and health authority licensure. You'll ... regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies ( FDA , EMA, JNDA, TGA). + **Leadership:** Establish, manage and support CMC… more
- Eliassen Group (Trenton, NJ)
- …main focal point for the component system, including data collection, data validation , meeting coordination, rollout execution, and progress updates + Perform risk ... actions + Ensure all written materials align with company, quality, and FDA guidelines across all manufacturing components **Experience Requirements:** + Ability to… more
- Integra LifeSciences (Plainsboro, NJ)
- …and approve quality documents requiring QA oversight (eg, IOPQ and validation protocols, Engineering Change Orders (ECO), deviations, OOS/OOT reports, DHR, Supplier ... and standards, and internal Standard Operating Procedures + Provide support in FDA inspections, ISO audits and customer audits at the CMC facility **DESIRED… more
- Sanofi Group (Bridgewater, NJ)
- …development activities (eg pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment) + Contribute to the clinical ... part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health… more
- Edgewell Personal Care (Allendale, NJ)
- …to identify systemic risks in regulatory and quality data flows + Support validation and accuracy of master data for compliance-critical fields + Design and ... Regulatory Affairs, or Operations Analytics + Exposure to regulatory standards such as FDA , EU MDR, ISO 13485 or GMP preferred + Experience with compliance tracking,… more