| Resume alert | Resumes 31 - 40 of 293 |
Environmental Health Hazardous Waste
Revere, MA
... Maintain all EHS programs in a GMP facility, permit/registrations, hazardous waste compliance, employee training, and emergency response oversight. Additional responsibilities include regulatory compliance with MWRA, OSHA, EPA, MADEP, MADPH, MADPS ... - 2023 Jul 07
... Maintain all EHS programs in a GMP facility, permit/registrations, hazardous waste compliance, employee training, and emergency response oversight. Additional responsibilities include regulatory compliance with MWRA, OSHA, EPA, MADEP, MADPH, MADPS ... - 2023 Jul 07
Protein purification process operation
Boston, MA
... • Supported an immunological-therapeutic product, completed charge variant assays and data analyses of over thousands of samples to support process development, process characterization, comparability, scale-up studies, GMP, PPQ and post-PPQ ... - 2023 Jun 22
... • Supported an immunological-therapeutic product, completed charge variant assays and data analyses of over thousands of samples to support process development, process characterization, comparability, scale-up studies, GMP, PPQ and post-PPQ ... - 2023 Jun 22
Time Delivery Customer Support
Boston, MA
... – Mumbai, INDIA Apr 2020 – Jan 2021 • Revamped production processes to meet GMP standards; created centralized document management system for BOM, SOP, SOW, as product specification & raw material disposition documents like QDR, CoA; decreased ... - 2023 Jun 10
... – Mumbai, INDIA Apr 2020 – Jan 2021 • Revamped production processes to meet GMP standards; created centralized document management system for BOM, SOP, SOW, as product specification & raw material disposition documents like QDR, CoA; decreased ... - 2023 Jun 10
Qa Analyst Quality Engineer
Randolph, MA
... Policy (POL-00187 Ver 2.0) GxP Computerized System Validation Procedure (SOP-11348 Ver 5.0) Good Documentation Practices (SOP-06262 Ver 9.0) GMP Data Integrity (POL-00119 Ver 4.0) GLPS_Global Drug Safety and Adverse Event Reporting Training. ... - 2023 Jun 08
... Policy (POL-00187 Ver 2.0) GxP Computerized System Validation Procedure (SOP-11348 Ver 5.0) Good Documentation Practices (SOP-06262 Ver 9.0) GMP Data Integrity (POL-00119 Ver 4.0) GLPS_Global Drug Safety and Adverse Event Reporting Training. ... - 2023 Jun 08
Document Reviewer Team Member
Billerica, MA
... under ISO 13485:2016 GMP IVD medical device regulations, adhered to quality system (QMS) documents, -As quality system resource, reached consensus on continuous process improvements, DocuSign management, supplier management,CAPA remediation. ... - 2023 Jun 07
... under ISO 13485:2016 GMP IVD medical device regulations, adhered to quality system (QMS) documents, -As quality system resource, reached consensus on continuous process improvements, DocuSign management, supplier management,CAPA remediation. ... - 2023 Jun 07
Regulatory Affairs CMC
Atlantic, MA, 02171
... SKILLS ● Strong knowledge of GCP, GMP, ICH and Health Authority guidances ● Quality by Design (QbD) ● Veeva Vault, Trackwise, Liquent InSight, GPRS, RAPIDdirect, Adobe Suite ● 21 CFR 314.420(G) - DMF ● eCTD structure ● Project management & Risk ... - 2023 May 22
... SKILLS ● Strong knowledge of GCP, GMP, ICH and Health Authority guidances ● Quality by Design (QbD) ● Veeva Vault, Trackwise, Liquent InSight, GPRS, RAPIDdirect, Adobe Suite ● 21 CFR 314.420(G) - DMF ● eCTD structure ● Project management & Risk ... - 2023 May 22
Regulatory Affairs Intern
Boston, MA
... RIM, Liquent Access, and Please Review Quality Control responsibilities: • Performed Quality testing of AAV based Gene Therapy GMP Samples, Processed, and Reviewed data • Hands on experience of UV-Visible Spectrophotometry, HPLC-SEC, and CE-SDS • ... - 2023 Apr 05
... RIM, Liquent Access, and Please Review Quality Control responsibilities: • Performed Quality testing of AAV based Gene Therapy GMP Samples, Processed, and Reviewed data • Hands on experience of UV-Visible Spectrophotometry, HPLC-SEC, and CE-SDS • ... - 2023 Apr 05
OSHA Outreach Trainer + Master Electrician
Boston, MA
... Pfizer Pharmaceuticals - Andover, MA EHS Manager GMP 03/2019 to 05/2022 • Maintain and oversee OSHA, State, and Company Safety programs as needed to facilitate a Safe Campus of 2500+ employees and Sub-contractors • Daily preform audits weekly and ... - 2023 Mar 21
... Pfizer Pharmaceuticals - Andover, MA EHS Manager GMP 03/2019 to 05/2022 • Maintain and oversee OSHA, State, and Company Safety programs as needed to facilitate a Safe Campus of 2500+ employees and Sub-contractors • Daily preform audits weekly and ... - 2023 Mar 21
Regulatory Affairs Chemist
Lowell, MA
... Solid working knowledge of Regulatory Submissions, Product labeling, Quality Assurance & Quality Systems, eCTD, GMP, GCP, GLP, Documentation, and Docketing. TECHNICAL SKILL Medical Device: 510(k), IDE, PMA, UDI, MDRs, ISO 13485, ISO 14971, DMR, DHR, ... - 2023 Feb 27
... Solid working knowledge of Regulatory Submissions, Product labeling, Quality Assurance & Quality Systems, eCTD, GMP, GCP, GLP, Documentation, and Docketing. TECHNICAL SKILL Medical Device: 510(k), IDE, PMA, UDI, MDRs, ISO 13485, ISO 14971, DMR, DHR, ... - 2023 Feb 27
Manager Integrated Management System
Somerville, MA
... Occupational Health & Safety Risk/ opportunity identification (OH&SMS ISO45001:2018), Identification & Mitigation of Greenhouse gases (GHG ISO14064-1), Adding to Good manufacturing Practice (GMP) 29.Development (Training) of 2nd level of IMS ... - 2023 Jan 09
... Occupational Health & Safety Risk/ opportunity identification (OH&SMS ISO45001:2018), Identification & Mitigation of Greenhouse gases (GHG ISO14064-1), Adding to Good manufacturing Practice (GMP) 29.Development (Training) of 2nd level of IMS ... - 2023 Jan 09