QA Engineer

Avantor is looking for a Quality Assurance Engineer to join our team in Solon, OH.  In this role, you will provide support for site product transfers as well as new business.   You will support multiple functions including Document Control, Calibrations (including site transition to e-Maintenance), Change Management, and Supplier Quality. 

This role will be a full-time, hybrid role (3 days per week onsite, 2 days remote).

What we’re looking for  

• Education: Bachelor of Science degree in Chemistry, Chemical Engineering, Material Science or related discipline.

• Experience: 3+ years’ experience in quality engineering role

• Knowledge of ISO 9001 and ISO 13485 preferred.

• Experience in chemical industry a plus.

• Working knowledge and experience with LEAN, Six Sigma methodologies.

• Working knowledge in Design of Experiments (DOE), and ability to manage implementation of improvements.

• Assist in validation processes including TM validation, manufacturing process validation, cleaning validation.

• Proficiency working with Microsoft Excel, Word.

• Experience with SAP and ETQ systems preferred.

• Understanding of statistical process and quality control principle.

• Skilled in metrology tools.

• Ability to work effectively in a team environment.

• Ability to identify problems and communicate solutions in a constructive and positive manner.

• Attention to detail; excellent organizational and record keeping skills.

• Internal auditor certification a plus.

• ASQ Certified Quality Engineer or are currently pursuing certification is preferred.

How you will thrive and create an impact  

• Responsible for Quality System maintenance.

• Performs root cause analysis and implementation of corrective action for process related issues.

• Identifies statistical methods relevant to the manufacturing process.

• Responsible for continual improvement activities to enhance the Quality System.

• Develops and performs training to build quality awareness throughout the company.

• Interfaces with Manufacturing, Research and Development and Engineering to ensure transfer of newly developed products that are in accordance with approved data and analysis.

• Conducts audits, including closing out audit findings, creating audits finding reports and works with cross functional teams to determine proper corrective and preventive actions.

• Assists in creation and maintaining quality documentation.

• Implements and maintains Statistical Process Control (SPC) for products and identifies potential process improvements.

• Conduct Active Pharmaceutical Ingredient product review.

• Evaluate impact of process improvement effort and manufacturing deviation on process validation and product design.

• Demonstrates good communication and project management skills.

• Collaborate with team members to support company goals.

• Develop experiments by applying full and fractional factorial techniques (DOE).

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
 
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
 
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.