| Resume alert | Resumes 61 - 70 of 525 |
Clinical Research Coordinator
Boston, MA
... Processed study documentation for compliance with FDA, site visits, agreements, and certifications/training of the study staff in accordance with study-specific TMF Plans and other applicable guidelines. Performed quality review of documents of the ... - 2023 Mar 03
... Processed study documentation for compliance with FDA, site visits, agreements, and certifications/training of the study staff in accordance with study-specific TMF Plans and other applicable guidelines. Performed quality review of documents of the ... - 2023 Mar 03
Regulatory Affairs Chemist
Lowell, MA
... TECHNICAL SKILL Medical Device: 510(k), IDE, PMA, UDI, MDRs, ISO 13485, ISO 14971, DMR, DHR, DMF Drugs and Biologics: pre-IND, IND, DMF, NDA, BLA, MAA, ANDA, Regulatory Submissions Compliance Audits: FDA Form 483, Warning Letters, Consent Decrees, ... - 2023 Feb 27
... TECHNICAL SKILL Medical Device: 510(k), IDE, PMA, UDI, MDRs, ISO 13485, ISO 14971, DMR, DHR, DMF Drugs and Biologics: pre-IND, IND, DMF, NDA, BLA, MAA, ANDA, Regulatory Submissions Compliance Audits: FDA Form 483, Warning Letters, Consent Decrees, ... - 2023 Feb 27
Systems Administrator It Support
Boston, MA
... Validated, Installed, and Troubleshoot ELN (electronic laboratory notebook) used in an FDA-regulated environment for pharmaceutical software. Imaged and upgraded Windows 8 to Windows 10 and performed post-migration support on laptops and desktops. ... - 2023 Feb 23
... Validated, Installed, and Troubleshoot ELN (electronic laboratory notebook) used in an FDA-regulated environment for pharmaceutical software. Imaged and upgraded Windows 8 to Windows 10 and performed post-migration support on laptops and desktops. ... - 2023 Feb 23
Inventory Specialist Customer Service
Boston, MA
... Skills include: Prescription Processing, Pharmaceutical Calculations, Medical & Pharmaceutical Terminology, Drug Classifications & Safety, Medication Inventory Management, FDA Compliance, Medicare, Medicaid & Insurance Claims Processing and Customer ... - 2023 Feb 19
... Skills include: Prescription Processing, Pharmaceutical Calculations, Medical & Pharmaceutical Terminology, Drug Classifications & Safety, Medication Inventory Management, FDA Compliance, Medicare, Medicaid & Insurance Claims Processing and Customer ... - 2023 Feb 19
Heavy Equipment Buyer Planner
Roslindale, MA
... certification process •Contracted FDA product safety certification requirement with Intertec, ETL Semko •Greater than $30K cost savings in 1999-2000, $50K in 2001-2002 •Interface with Engineering and manufacturing, Accounting and top level Mgmt. ... - 2023 Feb 09
... certification process •Contracted FDA product safety certification requirement with Intertec, ETL Semko •Greater than $30K cost savings in 1999-2000, $50K in 2001-2002 •Interface with Engineering and manufacturing, Accounting and top level Mgmt. ... - 2023 Feb 09
Sterile Processing Technician
Woburn, MA
... MEDICAL TERMINOLOGY, DISEASE PROCESSES, ANATOMY, AND PHYSIOLOGY EXCEPTINAL CUSTOMER SERVICE, COMMUNICATION SKILLS AND PROFESSIONALISM COMPLIANCE WITH HIPAA, OSHA, CDC, FDA, ANSI, AAMI, AND OTHER REGULATING AGENCIES KNOWLEDGE OF CENTRAL SERVICE ONE ... - 2023 Jan 31
... MEDICAL TERMINOLOGY, DISEASE PROCESSES, ANATOMY, AND PHYSIOLOGY EXCEPTINAL CUSTOMER SERVICE, COMMUNICATION SKILLS AND PROFESSIONALISM COMPLIANCE WITH HIPAA, OSHA, CDC, FDA, ANSI, AAMI, AND OTHER REGULATING AGENCIES KNOWLEDGE OF CENTRAL SERVICE ONE ... - 2023 Jan 31
Data Entry Pharmacovigilance Scientist
Lexington, MA
... • Knowledge about FDA regulations, pre-clinical and clinical requirements, IND submissions and meetings with FDA, cGMP requirements, FDA MedWatch programs. • Gained knowledge on how to review product labelling for compliance with global labelling ... - 2022 Dec 14
... • Knowledge about FDA regulations, pre-clinical and clinical requirements, IND submissions and meetings with FDA, cGMP requirements, FDA MedWatch programs. • Gained knowledge on how to review product labelling for compliance with global labelling ... - 2022 Dec 14
Pharmacovigilance/drug safety
West Roxbury, MA, 02132
... Assisted with FDA inspections within drug safety department. Education Widener University, Chester, PA - Pre-med Biology Universidad Iberoamericana, Santo Domingo, RD - Bachelor of Science, Health Science Washington University of Health and Sciences ... - 2022 Nov 30
... Assisted with FDA inspections within drug safety department. Education Widener University, Chester, PA - Pre-med Biology Universidad Iberoamericana, Santo Domingo, RD - Bachelor of Science, Health Science Washington University of Health and Sciences ... - 2022 Nov 30
Time Delivery Software Engineer
Boston, MA
... Comfortable with defining software verification and validation procedures in an FDA regulated environment. Skilled at resolving technical issues and conducting risk analysis activities. Accomplished communicator focused on strengthening ... - 2022 Nov 30
... Comfortable with defining software verification and validation procedures in an FDA regulated environment. Skilled at resolving technical issues and conducting risk analysis activities. Accomplished communicator focused on strengthening ... - 2022 Nov 30
Equipment Operator Assembly Technician
Lowell, MA
... II Applies technical knowledge and excellent hand/eye coordination to assemble semiconductor laser diode components, subassemblies, and other products according to approved drawings and written procedures while complying with FDA, ISO & ... - 2022 Nov 04
... II Applies technical knowledge and excellent hand/eye coordination to assemble semiconductor laser diode components, subassemblies, and other products according to approved drawings and written procedures while complying with FDA, ISO & ... - 2022 Nov 04