The Source Testing Quality Manager (QM) reports directly to the Director of Quality. Execute and maintain the Quality Management System detailed in the Alliance Quality Management Plan for Source Testing. We are hiring a Source Testing Quality Manager to support our Alliance Source Testing (AST) bus...
Responsible for execution and performance of Lantheus CQA quality system elements including audit programs, inspection preparation support, continuous improvement, and quality system procedural documents. BS degree in a scientific discipline and minimum of 7 years' experience in the pharmaceutical o...
You'll be the guardian of quality documentation, overseeing tasks like scanning documents into the electronic document management system (eDMS), archiving historical documents, and revising standard operating procedures (SOPs) for accuracy and clarity. ...
The Senior Manager of Quality Assurance will be responsible for overseeing all aspects of quality assurance activities related to the design, development, manufacturing, and distribution of their Class II medical devices. Lead and mentor a team of quality assurance professionals, providing guidance ...
Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in providing GCP Quality Assurance and Compliance support with respect to planning, execution and close-out of clinical programs. Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations,...
Preferred Knowledge, Skills, Education, and Experience: .Prior Medical Device/Biotech experience.Prior experience with a Document Control Platform such as Arena or Agile.Ability to work semi-independently within a regulated environment....
Quality role at a GMP manufacturing environment (combination of Quality Assurance and Quality Control experience preferred). This position is part of Moderna’s Quality Assurance team responsible for ensuring quality oversight of our mRNA platform in cGMP Manufacturing. The main responsibility for th...
The Director of Clinical Quality Assurance is responsible for leading Good Clinical Practice (GCP) Quality Assurance (QA) and serves as the GCP Quality representative for clinical study teams. Primary Responsibilities Include:Provide leadership and operational management for all Dyne Clinical Qualit...
Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records. ...
As a Senior Specialist, Quality Assurance (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility located in Bedford, MA. Execute Quality Assurance procedures for material inspection and disposition, at ...
Quality Assurance Engineer is responsible for product and process quality through implementing and maintaining Quality Assurance Programs & Plans, an ISO 9001 Quality Management System, and process improvement initiatives. Suppliers; and work with key suppliers to drive improvement in quality, cost,...
Designs, creates, and monitors all quality processes to test applications. Conducts project quality audits. Experience with managing data in a regulated quality system. Understanding of GXP compliance and requirements as they apply to quality systems. ...
Job Title: Quality - Investigator - Quality Assurance (Mid Level). Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records. ...
Position Summary The Vice President, Quality Assurance is a critical leadership position responsible for the phase-appropriate conceptualization, implementation, and management of Affini-T Therapeutic’s corporate quality systems to support the company’s advancement of a broad pipe...
Commercial Banking Credit Underwriting Quality Assurance AssociateCountry: United States of America. The Commercial Banking Credit Underwriting Quality Assurance Associate (Associate, Risk Management) leverages their subject matter expertise in second line defense to improve existing processes and p...
Senior Quality/GxP Auditor Responsibilities:. ...
As a quality assurance associate, you will be responsible for inspecting materials and packaging to make sure they meet quality requirements. As a quality assurance associate, you will be responsible for inspecting materials and packaging to make sure they meet quality requirements. ...
Primary task will be Quality Assurance testing before application deployment. Quality Assurance Testing for Windows Tests software packages according to defined set of criteria and document results Identify potential risks with software installation and stability of programs Notify team members for ...
Assist Quality Inspectors in ensuring the highest quality products by being involved in the quality checks in production (capsule weights, cleanliness checks, weighing room, bottling line checks, etc. Assist Quality Inspectors in ensuring the highest quality products by being involved in the quality...
We are seeking a Quality Assurance Analyst to join our team. Knowledgeable of concept practices and procedures commonly used in software quality assurance. Effective testing skills:proficient in test planning and execution and using test methodologies to identify software defects, applying software ...
Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations. Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations. Minimum years of experie...
Document Control, Inspection, and Quality Assurance. Minimum 2 years of Document Control, Inspection, and Quality Assurance experience. Ensuring document accuracy (Quality) regarding numbering formatting, revisions, and content per approved changes. ...
Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records. ...
The position requires significant cross-functional coordination between Controls, Mechanical, Electrical, Firmware and Quality teams. ...
This position will be responsible for Quality Operations support of internal clinical manufacturing at the Editas Waltham and Devens GMP manufacturing facilities as a member of the Quality Operations team. Support Editas’ clinical cell manufacturing facilities in Waltham, MA and Devens, MA as a memb...