Senior Quality Associate

Azenta Life Sciences-posted 2 months ago

$76,000 - $95,000/Yr

Full-time • Mid Level

Indianapolis, IN

1,001-5,000 employees

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The Senior Quality Associate will provide direction and leadership to global personnel regarding operational compliance to all applicable federal and local guidelines. The Sr QA will create and implement policies and procedures which result in attaining quality goals and GxP globally.

Comply with, enforce, and be held accountable for all GxP Practices and Quality Control Procedures.
Independently schedule and host client audits; respond to audit findings in a timely manner.
Conduct internal audits for all Azenta Life Sciences facilities, including regional and client sites.
Routinely review and approve equipment validation documents such as temperature mapping, calibration, alarm validation, etc.
Compile the Management Review Meeting Presentation, including interpretation of data, charts, etc.
Process and review change requests for Global Operations.
Acts as system administrator for the Quality Management Software System.
Compile the department metrics utilizing reporting tools, including interpretation of data, creation of charts, etc.

Four-year degree, preferred Life Sciences/Engineering.
4 years’ experience in Quality Assurance in a GxP facility or a combination of 2 years in Quality Assurance plus another 2 years' experience in a regulated industry.
Experience with regulatory audits and/or customer audits in a regulated environment.
Strong analytical skills and the ability to think creatively.
Strong verbal and written communication and interpersonal skills.
Demonstrated high level of initiative and ability to work independently.

Experience with software/hardware validation.
Experience with supplier management.
Training in GAMP or other ISPE validation courses.
Experience writing and managing SOP’s and Quality Assurance and Business Policies.

Base Compensation: $76,000.00 - $95,000.00
Equal Opportunity Employer

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