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Senior Quality Associate
3 months ago
Company Overview
At Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer-focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.
Azenta Life Sciences is a global leader in the life sciences space with headquarters in Burlington, MA, and offices and operations worldwide. We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. We provide unparalleled capabilities with our lab analysis, sample management and storage services, informatics software, and consumables, with the largest installed base managing over 1 billion samples globally.
How You’ll Add Value
The Senior Quality Associate, CRS will provide quality assurance support for Customer and Regional sites. They will be expected to comply with, enforce, and be held accountable for GxP Practices and Quality Control Procedures.
What You’ll Do
Independently schedule and host client audits and respond to audit findings in a timely manner.
Conduct internal audits for all North American Azenta Life Sciences facilities, including regional and client sites.
Assists with implementation and improvement of quality system globally within Azenta Life Sciences through gap analysis and remediation – as needed.
Routinely reviews and approves equipment validation documents – such as temperature mapping, calibration, alarm validations, etc.
Compiles the Management Review Meeting Presentation, including interpretation of data, charts, etc.
Reviews Change Request for Global Operations
Provides direction and leadership to ensure compliance with GxPs, ISO 9001, federal and local guidelines and regulations at Customer and Regional Sites.
Provides regional QA support, as needed
Acts as system administrator in Qualtrax.
What You Will Bring
Four-year degree, preferred Life Sciences/ Engineering
4 years’ experience in Quality Assurance
Experience performing internal audits
Experience with ISO 9001
Strong analytical skills and the ability to think creatively
Excellent leadership skills and the ability to work across the organization
Strong communication, interpersonal, and collaborative skills
Demonstrated high level of initiative and the ability to work independently
Proficiency in Microsoft Office Products
Experience in GxP facility preferred
Experience with Continuous Improvement initiatives preferred
Experience with project management preferred
Six Sigma certification preferred
Your Working Conditions:
May work with potentially infectious materials.
Responsible for maintaining a clean work environment and enforcing and following Universal Precautions for bloodborne pathogens when working in areas considered to be potentially contaminated
EOE M/F/Disabled/VET
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