| Resume alert | Resumes 41 - 50 of 525 |
Quality Assurance Supply Chain
Norwood, MA
... • Managed the reconciliation of method development and validation, GLP compliance, documentation, completeness, and compliance per FDA guidelines, following SOPs, protocols, QA compliance, and a review checklist. Academic Project • Conducted a ... - 2023 Aug 29
... • Managed the reconciliation of method development and validation, GLP compliance, documentation, completeness, and compliance per FDA guidelines, following SOPs, protocols, QA compliance, and a review checklist. Academic Project • Conducted a ... - 2023 Aug 29
Supply Chain Operations Manager
Medford, MA
... Quality and Supplier Qualifications and ISO 9001-2015 and FDA 13485 certifications audits. Persimmon Technologies Wakefield, MA June 2014 – June 2016 Senior Material Program Manager Materials Program Manager for Robotics manufacturer supporting the ... - 2023 Aug 07
... Quality and Supplier Qualifications and ISO 9001-2015 and FDA 13485 certifications audits. Persimmon Technologies Wakefield, MA June 2014 – June 2016 Senior Material Program Manager Materials Program Manager for Robotics manufacturer supporting the ... - 2023 Aug 07
Product development engineer
Lowell, MA
... Recall Technician - Temporary Nova Biomedical - Billerica, MA September 2013 to November 2013 Involved in a regulatory compliant FDA recall of blood glucose test strips. Initiated RMA log sheets by confirming consumer demographics and expected ... - 2023 Jul 21
... Recall Technician - Temporary Nova Biomedical - Billerica, MA September 2013 to November 2013 Involved in a regulatory compliant FDA recall of blood glucose test strips. Initiated RMA log sheets by confirming consumer demographics and expected ... - 2023 Jul 21
Drug Safety Specialist
Boston, MA
... ● Process Individual Case Study Reports (ICSR) and serious adverse event (SAE) reports including case intake, duplicate check, data entry, generation of narratives, MedDRA coding, quality checks, submissions to FDA through gateway; ● Submission of ... - 2023 Jul 10
... ● Process Individual Case Study Reports (ICSR) and serious adverse event (SAE) reports including case intake, duplicate check, data entry, generation of narratives, MedDRA coding, quality checks, submissions to FDA through gateway; ● Submission of ... - 2023 Jul 10
Quality Assurance Set Up
Somerville, MA
... Ensure strict compliance with quality system regulations 21 CFR 820, ISO 13485 / 9001, current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), Food and Drug Administration (FDA), OSHA, and ... - 2023 Jul 10
... Ensure strict compliance with quality system regulations 21 CFR 820, ISO 13485 / 9001, current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), Food and Drug Administration (FDA), OSHA, and ... - 2023 Jul 10
Electrical Engineer Project Manager
Wayland, MA
... FDA, FMEA; IEC60601, OrCAD and Altium capture. 2022 – current Senior Electrical Engineer, Gener8, Woburn MA Medical Device schematic development, BOM, prototyping, testing. 2019 – 2022 Principal Electrical Engineer, Epam Systems, Boston MA Hardware ... - 2023 Jul 03
... FDA, FMEA; IEC60601, OrCAD and Altium capture. 2022 – current Senior Electrical Engineer, Gener8, Woburn MA Medical Device schematic development, BOM, prototyping, testing. 2019 – 2022 Principal Electrical Engineer, Epam Systems, Boston MA Hardware ... - 2023 Jul 03
Protein purification process operation
Boston, MA
... Process Support & Development Scientist, Biologics Technical Operations, Specialty Products Division, Abbott Laboratories, North Chicago, IL 1999 to 2005 • Performed process validation and justification studies to meet FDA requirements. • Supported ... - 2023 Jun 22
... Process Support & Development Scientist, Biologics Technical Operations, Specialty Products Division, Abbott Laboratories, North Chicago, IL 1999 to 2005 • Performed process validation and justification studies to meet FDA requirements. • Supported ... - 2023 Jun 22
Chief Product Supply Officer
Boston, MA, 02109
... A hands-on executive that has significant FDA, international manufacturing, engineering, quality, procurement, distribution & fulfilment, turnaround and hypergrowth experience. Extensive experience working with boards and generating funding. ... - 2023 Jun 16
... A hands-on executive that has significant FDA, international manufacturing, engineering, quality, procurement, distribution & fulfilment, turnaround and hypergrowth experience. Extensive experience working with boards and generating funding. ... - 2023 Jun 16
Document Reviewer Team Member
Billerica, MA
... ● Technical lead - biomarker IHC assay projects, submitted to FDA (immuno-drug conjugate assays) in support of Phase I/II clinical trials ● Wrote standard work, assay development procedures, final GLP reports. ● Authored portions of IND submissions, ... - 2023 Jun 07
... ● Technical lead - biomarker IHC assay projects, submitted to FDA (immuno-drug conjugate assays) in support of Phase I/II clinical trials ● Wrote standard work, assay development procedures, final GLP reports. ● Authored portions of IND submissions, ... - 2023 Jun 07
Safety Specialist Regulatory Affairs
Boston, MA
... I worked for QA, gap analysis, and validation, with a strong focus on ensuring compliance with FDA regulations. I am now seeking a role as a Regulatory Affairs Associate in the biotechnology and medical device industries where I can leverage my ... - 2023 Jun 01
... I worked for QA, gap analysis, and validation, with a strong focus on ensuring compliance with FDA regulations. I am now seeking a role as a Regulatory Affairs Associate in the biotechnology and medical device industries where I can leverage my ... - 2023 Jun 01