| Resume alert | Resumes 71 - 80 of 619 |
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
Entry level Clinical Research
Edison, NJ
... FDA-ICH (International Council of Harmonization) guidelines GCP (good clinical practices) guidelines, GVP (good pharmacovigilance practices). Proficient in MS Office (MS Word, MS Excel, Power Point) Professional Experience Drug Safety and ... - 2023 Nov 06
... FDA-ICH (International Council of Harmonization) guidelines GCP (good clinical practices) guidelines, GVP (good pharmacovigilance practices). Proficient in MS Office (MS Word, MS Excel, Power Point) Professional Experience Drug Safety and ... - 2023 Nov 06
Business Analyst / Customer Service
Levittown, PA
... Responsible for providing website/email launch documentation required by the FDA. Managed website/email campaign implementations as well as post-production data capture. Oversaw the code review process upon receiving initial assets to ensure the ... - 2023 Nov 04
... Responsible for providing website/email launch documentation required by the FDA. Managed website/email campaign implementations as well as post-production data capture. Oversaw the code review process upon receiving initial assets to ensure the ... - 2023 Nov 04
Supply Chain Project Management
New Brunswick, NJ, 08989
... Monitor, organize and execute all functions associated with packaging of pharmaceutical commercial products and ensuring compliance with cGMP, SOP, FDA, DEA and OSHA rules and regulations. Accountability of manpower utilization, departmental ... - 2023 Oct 30
... Monitor, organize and execute all functions associated with packaging of pharmaceutical commercial products and ensuring compliance with cGMP, SOP, FDA, DEA and OSHA rules and regulations. Accountability of manpower utilization, departmental ... - 2023 Oct 30
Quality Control Associate
Robbinsville Center, NJ
... as per ICH guidelines Evaluation Tests - Disintegration Time, Friability, Dissolution, Particle size Analysis, DSC, Colorimeter Supported in FDA Audit by providing necessary documentation, protocols, procedures Dissolution Apparatus. UV ... - 2023 Oct 24
... as per ICH guidelines Evaluation Tests - Disintegration Time, Friability, Dissolution, Particle size Analysis, DSC, Colorimeter Supported in FDA Audit by providing necessary documentation, protocols, procedures Dissolution Apparatus. UV ... - 2023 Oct 24
Strategic Business Quality Control
Franklin Park, NJ
... Experience in dealing with FDA and DEA while ensuring the safe and efficient execution of job duties. Troubleshoot and make appropriate adjustments to maintain production specifications. Adhere to quality standards during the manufacturing process. ... - 2023 Oct 23
... Experience in dealing with FDA and DEA while ensuring the safe and efficient execution of job duties. Troubleshoot and make appropriate adjustments to maintain production specifications. Adhere to quality standards during the manufacturing process. ... - 2023 Oct 23
Medical Writer
Somerset, NJ
... • Educated colleagues and healthcare providers regarding new medications recently approved by the FDA. Walgreens Specialty Pharmacy Pharmacy Extern March 2023 – April 2023 • Counseled patients on their discharge medications and conducted ... - 2023 Oct 22
... • Educated colleagues and healthcare providers regarding new medications recently approved by the FDA. Walgreens Specialty Pharmacy Pharmacy Extern March 2023 – April 2023 • Counseled patients on their discharge medications and conducted ... - 2023 Oct 22