| Resume alert | Resumes 51 - 60 of 710 |
Quality Control Specialist
Somerset, NJ, 08873
... Knowledge of GMP, ISO, and FDA regulations and audit Experience with environmental monitoring, air and water sampling with GMP regulations. Performed Cross Functional Lab audits for FDA Inspection. Worked according to the approved validation ... - 2023 Dec 07
... Knowledge of GMP, ISO, and FDA regulations and audit Experience with environmental monitoring, air and water sampling with GMP regulations. Performed Cross Functional Lab audits for FDA Inspection. Worked according to the approved validation ... - 2023 Dec 07
Senior Manager Statistical Programming
Monroe Township, NJ, 08831
... • Creation and validation of E-submission requirements to the FDA which involved – creating annotated CRF, SAS transport files (XPT files), SDTM and ADaM, Define.xml documents, Reviewer’s guide etc. • Having achieved excellent organizational and ... - 2023 Dec 06
... • Creation and validation of E-submission requirements to the FDA which involved – creating annotated CRF, SAS transport files (XPT files), SDTM and ADaM, Define.xml documents, Reviewer’s guide etc. • Having achieved excellent organizational and ... - 2023 Dec 06
Customer Service Account Executive
Newtown, PA
... VP, National Accounts, Eurand Pharmaceuticals, Milan, Italy/Yardley, PA 4/2009 - 5/2011 Responsible for a start-up company, with the launch of FDA approved products into the US. Sales from $0 to $145M first year, Exceeding fist year expectations by ... - 2023 Dec 03
... VP, National Accounts, Eurand Pharmaceuticals, Milan, Italy/Yardley, PA 4/2009 - 5/2011 Responsible for a start-up company, with the launch of FDA approved products into the US. Sales from $0 to $145M first year, Exceeding fist year expectations by ... - 2023 Dec 03
Project Management Senior Manager
Fairless Hills, PA
... by 15% and healthcare membership initiatives by 9% Conducted market research & identified solutions to challenges faced by FDA regulations for external stakeholders SENIOR REGIONAL MARKETING MANAGER, 2008 to 2012 DOW JONES & COMPANY, South ... - 2023 Nov 29
... by 15% and healthcare membership initiatives by 9% Conducted market research & identified solutions to challenges faced by FDA regulations for external stakeholders SENIOR REGIONAL MARKETING MANAGER, 2008 to 2012 DOW JONES & COMPANY, South ... - 2023 Nov 29
Supply Chain Associate Director
Dayton, NJ
... • Planned Equipment & Time Constraints • Performance Reporting & Updates • International Regulations & Customs • Import/Export & FDA/DEA Experience • Proactive & Responsive Customer Service • Excellent Verbal & Written Communication Work Experience ... - 2023 Nov 27
... • Planned Equipment & Time Constraints • Performance Reporting & Updates • International Regulations & Customs • Import/Export & FDA/DEA Experience • Proactive & Responsive Customer Service • Excellent Verbal & Written Communication Work Experience ... - 2023 Nov 27
Quality Control Manufacturing Engineer
Freehold, NJ
... Design Assembly Automation Pro-e Cad Design Fixturing and Tooling Die Casting CNC Machining – 4th and 5th Axis CNC Programing FDA ISO OSHA Regulatory Compliance EXPERIENCE 10/2021- present Caes Inc Manufacturing Engineer Kaizen events, Cell design, ... - 2023 Nov 23
... Design Assembly Automation Pro-e Cad Design Fixturing and Tooling Die Casting CNC Machining – 4th and 5th Axis CNC Programing FDA ISO OSHA Regulatory Compliance EXPERIENCE 10/2021- present Caes Inc Manufacturing Engineer Kaizen events, Cell design, ... - 2023 Nov 23
CSV Specialist, Compliance Specialist, Quality Control and AR&D Lab
Hillsborough, NJ
... Department • 2 years of GMP quality compliance/quality assurance experience • Extensive knowledge of GAMP 5, ICH Guidance, FDA regulations including CSA (draft), EU Annex, MHRA, and OECD Guidelines, FDA’s Pre-Approval Inspection (PAI) Program • ... - 2023 Nov 17
... Department • 2 years of GMP quality compliance/quality assurance experience • Extensive knowledge of GAMP 5, ICH Guidance, FDA regulations including CSA (draft), EU Annex, MHRA, and OECD Guidelines, FDA’s Pre-Approval Inspection (PAI) Program • ... - 2023 Nov 17
Quality Assurance Business Development
Somerset, NJ
... Broad knowledge of Environmental monitoring, microbiology, Regulatory submissions including IND, ANDA and NDA, Annual Product Review, Process Validation: GxP, cGMP, cGLP, cGCP, GDP, FDA, ANVISA and MHRA regulations, DEA, EMA, USP, EP and ICH ... - 2023 Nov 16
... Broad knowledge of Environmental monitoring, microbiology, Regulatory submissions including IND, ANDA and NDA, Annual Product Review, Process Validation: GxP, cGMP, cGLP, cGCP, GDP, FDA, ANVISA and MHRA regulations, DEA, EMA, USP, EP and ICH ... - 2023 Nov 16
Project Management Safety Monitoring
Princeton, NJ, 08544
... •Knowledge in ICH, FDA, and EU guidelines. •Excellent written and interpersonal communication skills with international conference presentations and peer-reviewed journal publications. •Recipient of GOLD MEDAL, Meritorious Student Award, Doctoral ... - 2023 Nov 13
... •Knowledge in ICH, FDA, and EU guidelines. •Excellent written and interpersonal communication skills with international conference presentations and peer-reviewed journal publications. •Recipient of GOLD MEDAL, Meritorious Student Award, Doctoral ... - 2023 Nov 13
Quality Assurance Operations
Monmouth Junction, NJ
... Successfully navigated FDA audits and facilitated regulatory submissions. • Proficient in batch record review and release, APQR, Stability and Retain Sample Management, and handling of Product Complaints. • Highly process-oriented approach to ... - 2023 Nov 10
... Successfully navigated FDA audits and facilitated regulatory submissions. • Proficient in batch record review and release, APQR, Stability and Retain Sample Management, and handling of Product Complaints. • Highly process-oriented approach to ... - 2023 Nov 10