Associate Quality Assurance Engineer

Associate Quality Assurance Engineer at Exact Sciences summary:

The Associate Quality Assurance Engineer supports manufacturing operations by validating processes, reviewing quality compliance, and managing investigations to ensure materials meet regulatory standards. This role requires collaboration with cross-functional teams to maintain adherence to cGMP, ISO, and other quality regulations while driving process improvements. The position demands hands-on involvement in documentation, audits, and approval of manufacturing changes with a focus on quality and operational excellence in a biotech manufacturing environment.

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At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

Position Overview

The Associate Quality Assurance Engineer will provide support to Operations for a variety of functions such as material receipt, production, process validation, facility qualification, and test method validation to determine the acceptability of material and the process in which it was manufactured. The position may lead or assist in developing and documenting new procedures for Operations and Quality Engineering. The position will also serve as a Subject Matter Expert for the Operations group to support day-to-day activities through investigation management and evaluating material for release to distribution.

This position will operate independently with periodic supervision.

Essential Duties

Include, but are not limited to, the following:

• Participate as a Quality representative on process improvement projects and by interpreting Quality compliance with proposed changes.
• Partner with and provide support to Operations personnel in the completion of production documents, executed test methods to evaluate material prior to releasing for commercial distribution.
• Determine process risks and evaluate mitigations.
• Review executed protocols to determine process validation, test method validations, and equipment qualifications/validations were completed appropriately and ensure deficiencies are corrected prior to using the for commercial production.
• Review equipment calibration records.
• Review and approve changes to SOPs and Manufacturing Work Instructions (WI) to ensure compliance with relevant regulatory (cGMP, ISO, ICH) regulations.
• Provide Operations support for Nonconformance Reports and Deviations and approve disposition of material.
• Actively audits production and support areas to ensure compliance with internal SOPs and relevant regulatory (cGMP, ISO, ICH) regulations.
• Perform other related duties as assigned by management.
• Ability to frequently and accurately communicate with employees in person, via the telephone or by email.
• Proven ability to work effectively with and through multi-functional teams to achieve results.
• Excellent interpersonal skills with the ability to collaborate closely with Operations staff at varying levels to drive compliance and operational excellence.
• Excellent oral and written communication skills.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Regular and reliable attendance.
• Ability to work designated schedule.
• Ability to lift up to 40 pounds for approximately 25% of a typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability and means to travel between Madison locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.
• Ability to work onsite at least 90% of the time.

Minimum…