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.
- 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.
- Bachelor's degree in an engineering or science field with focus on biology and/or chemistry, or related field or an Associate degree with an additional 2 years of experience.
- 2+ years of experience in a manufacturing operation environment.
- 1+ years of experience in Quality principles and practice.
- Knowledge and experience working within an CFR 820, ISO 13485, ISO 9001 and/or cGMP structured environment.
- Authorization to work in the United States without sponsorship.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- 2+ years of experience in a biotech manufacturing environment, preferably in a GMP and/or ISO13485 environment. #LI-SM2
The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible.