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FDA jobs in Cambridge, MA

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Director of Quality Operations

EPM Scientific  –  Cambridge, MA
... Oversee implementation and adherence to cGMP, ICH, FDA, and ISO quality standards. Maintain and oversee a robust quality management system. Collaborate effectively with cross-functional teams to ensure seamless product launches. Proactively identify ... - Jun 15

Human Research Compliance and Auditing Specialist

Mass General Brigham  –  Somerville, MA, 02145
... IRB-approved clinical research protocols across our institutions to ensure compliance with FDA, OHRP and other state and government regulations, Good Clinical Practice (GCP) guidelines, as well as with our organization's clinical research policies. ... - May 25

Project Manage(onsite)

SmartIPlace  –  Boston, MA
... Representing Alexion as point contact FDA and leading Alexion delegation for regulatory authority meetings. Leading US submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial protocols, ... - Jun 10

Senior Quality Engineer

Global Life Science Hub  –  Lexington, MA
... At least 3 years of relevant experience in Quality Management within an FDA-regulated environment, ideally in the medical device or in vitro diagnostics industry. ASQ or Six Sigma Certification or equivalent is preferred. Strong knowledge of FDA ... - Jun 07

Electric Pallet Jack Operator

Wicked Staffing Solutions  –  Chelsea, MA
... Adheres to all current Good Manufacturing Practices (cGMPs) per the Food and Drug Administration (FDA). Follows and enforces all Standard Operating Procedures (SOPs) regarding production processing tasks and protocols. Conducts pre-hire and practice ... - Jun 14

Delivery Driver (non-CDL)

North Coast Seafoods  –  Boston, MA
... manipulation, pushing and pulling Work requires the following motions: bending, twisting, squatting and reaching Exposure to FDA approved cleaning chemicals Exposure to temperatures: <32 degrees Fahrenheit Ability to work in wet and dry conditions ... - Jun 03

Manufacturing Deviation and Investigations Writer

Experis  –  Cambridge, MA, 02142
... Experience in GMP Biopharma organization Experience with SAP, Deviation systems Performing and documenting investigations using 5 Whys’, DMAIC, Demonstrate a sound understanding of cGMP's, FDA regulations, and pharmaceutical manufacturing/packaging ... - Jun 12

Director of Regulatory and Quality

Michael Page  –  Danvers, MA, 01923
Reporting into the General manager, The Director of Quality & Regulatory will maintain and enhance the current ISO 13485, FDA cGMP and Canadian Medical Devices Conformity Assessment System (CMDCAS), Complaint system, and Quality Management System ... - Jun 11

Production Manager

Judge Direct Placement  –  Boston, MA, 02298
... management Ensure that production meets quality and food safety standards, including adherence to regulatory requirements (e.g., FDA, USDA) Monitor production processes and identify opportunities for improvement in efficiency, quality, and cost ... - Jun 02

Senior Manager, Regulatory Affairs

Editas Medicine  –  Cambridge, MA
... Regulatory Agency Interactions: Support the regulatory lead in preparing for Health Authority meetings with agencies, including the FDA, EMA, and other global regulatory authorities, representing the company in regulatory interactions, meetings, and ... - Jun 02
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