| Resume alert | Resumes 31 - 40 of 648 |
General Counsel Law Clerk
Chatham, NJ, 07928
... and Amgen Manufacturing Ltd., in response to clients’ submission to FDA of a license application for Amjevita® (adalimumab-atto) as a biosimilar to plaintiffs’ Humira® (adalimumab) reference product for treating multiple inflammatory diseases, ... - Jan 20
... and Amgen Manufacturing Ltd., in response to clients’ submission to FDA of a license application for Amjevita® (adalimumab-atto) as a biosimilar to plaintiffs’ Humira® (adalimumab) reference product for treating multiple inflammatory diseases, ... - Jan 20
Data Analyst Accounts Payable
Edison, NJ
... Sample products examine for FDA Validation of bulk & finished products manufactured by contractors prior to release. Performed the review and disposition of batch manufacturing and packaging records. Reviewed Certificates of Analysis and Compliance ... - Jan 18
... Sample products examine for FDA Validation of bulk & finished products manufactured by contractors prior to release. Performed the review and disposition of batch manufacturing and packaging records. Reviewed Certificates of Analysis and Compliance ... - Jan 18
Quality Assurance Regulatory Affairs
Irvington, NJ
... s production activities comply with government regulation SUMMARY OF TECHNICAL SKILLS High level of understanding of applicable regulations, including FDA (21CFR 312 and 314), ICH (E2A, E2B, E2C), GCP guidelines, EMA regulations, GVP Modules, etc. ... - Jan 15
... s production activities comply with government regulation SUMMARY OF TECHNICAL SKILLS High level of understanding of applicable regulations, including FDA (21CFR 312 and 314), ICH (E2A, E2B, E2C), GCP guidelines, EMA regulations, GVP Modules, etc. ... - Jan 15
Analytical Test Development
Piscataway, NJ
... Improved Quality Operation of team for GMP audit, FDA and Health Canada site inspection. Managed analysts training and performance using iShift and ADP. Scientist, QC Analytical Excellence Department (May 2021 – May 2022) Oversaw/ led ... - Jan 12
... Improved Quality Operation of team for GMP audit, FDA and Health Canada site inspection. Managed analysts training and performance using iShift and ADP. Scientist, QC Analytical Excellence Department (May 2021 – May 2022) Oversaw/ led ... - Jan 12
Quality Control Machine Operator
Elizabeth, NJ
... • Manufacturing (9 years) • Food Production (10+ years) • OSHA,PPE, FDA,SOP, Table Press (5 years) • Lean Manufacturing • Assembly • Leadership • Quality control • Continuous improvement • Team management • Single Punch Table Press, Pill Press. ... - Jan 09
... • Manufacturing (9 years) • Food Production (10+ years) • OSHA,PPE, FDA,SOP, Table Press (5 years) • Lean Manufacturing • Assembly • Leadership • Quality control • Continuous improvement • Team management • Single Punch Table Press, Pill Press. ... - Jan 09
Project Manager Clinical Trial
Elizabeth, NJ
... approach Strong Knowledge of GCPs, FDA, and ICH requirements Superior work ethics Excellent interpersonal and leadership skills with an eye for detail Excellent knowledge of MS Word, Access, Excel, Teams, Skype, One Note, Zoom, and Share drives. ... - Jan 05
... approach Strong Knowledge of GCPs, FDA, and ICH requirements Superior work ethics Excellent interpersonal and leadership skills with an eye for detail Excellent knowledge of MS Word, Access, Excel, Teams, Skype, One Note, Zoom, and Share drives. ... - Jan 05
Senior Director Quality Control
Piscataway, NJ
... all processes and documents for digital FDA review remotely. •Developed company expansion capacity models and execute resourcing strategies to ensure delivery of activities and scopes of work from various internal teams and external consultants ... - Jan 02
... all processes and documents for digital FDA review remotely. •Developed company expansion capacity models and execute resourcing strategies to ensure delivery of activities and scopes of work from various internal teams and external consultants ... - Jan 02
Statistical Programmer Customer Service
Edison, NJ
... • Provided further analysis as requested by FDA after submission. Carried out new analyses on past studies and designed tables to display information. • • Produced patient profiles listings for oncology studies. Created standard and custom reports ... - Jan 02
... • Provided further analysis as requested by FDA after submission. Carried out new analyses on past studies and designed tables to display information. • • Produced patient profiles listings for oncology studies. Created standard and custom reports ... - Jan 02
.Net Core C C++
Little Falls, NJ
... Developed Web Driven Patient Information Management System (Panacare/FDA/VA). Developed Panasonic’s Order, Backorder and Sales Reporting Systems. Tasks, Tools, and Environments are used for the above projects: Windows 2000/XP, Visual Basic 6, ... - 2023 Dec 31
... Developed Web Driven Patient Information Management System (Panacare/FDA/VA). Developed Panasonic’s Order, Backorder and Sales Reporting Systems. Tasks, Tools, and Environments are used for the above projects: Windows 2000/XP, Visual Basic 6, ... - 2023 Dec 31
Medical Science Liaison
Morristown, NJ
... activities including ramp up of disease state awareness before FDA approval, vetting and speaking to KOLs, and increasing disease state education for VIVJOA (Oteseconazole) an anti-infective for Candida Albicans and other Candida species. ... - 2023 Dec 25
... activities including ramp up of disease state awareness before FDA approval, vetting and speaking to KOLs, and increasing disease state education for VIVJOA (Oteseconazole) an anti-infective for Candida Albicans and other Candida species. ... - 2023 Dec 25