The Opportunity:

At Avantor, people are the most important part of our success because they drive our global performance. That’s why our Operations, Lab Services, Sales, and many other Avantor teams rely on our talent acquisition initiatives to attract, engage and hire the right talent. Avantor’s Quality Assurance & Quality Systems vertical is a crucial part of this mix, enabling all our internal teams worldwide to grow beyond their limits.

The Quality Assurance Manager is responsible for developing and upholding QA procedures and techniques. Collaborate with manufacturing, engineering, and customers to resolve product quality issues. Advise leadership on continuous improvement to align systems with company strategy. Provide technical input for process and documentation changes. Manage a large team, focusing on policy, strategy, and short-term operational plans.

This is an onsite position reporting to the Senior Manager of Quality Assurance at our Paris, KY chemical manufacturing facility.

What we’re looking for

Education: Bachelor’s Degree in a related scientific discipline (e.g., Biochemistry, Chemistry, Molecular Biology)Experience: Minimum 5 years of applicable work experience is required; 3+ years' experience in a GMP environment and quality, auditing, and/or project management is preferredCollaboration Tool: Advanced Microsoft Office (Excel, Visio, PowerPoint, etc) experience highly preferred Preferred Qualifications: ASQ Quality Certification1+ year of people management/leader experienceSAP experience

How you will thrive and create an impact

Direct the activities for the quality organization at the facility.Manage, organize, and oversee QA objectives in line with corporate, site quality, and business goals.Develop, manage, and maintain the quality management system to meet regulatory requirements and international quality standards.Ensure products meet customer quality expectations and requirements.Develop, monitor, and manage the departmental budget.Ensure timely closure of non-conformances, failure investigation reports, and corrective/preventive actions.Develop strategies for continuous improvement.Oversee writing, revision, implementation, and training of standard operating procedures and work instructions for area of responsibility.Communicate with customers regarding quality-related issues and complaints.Review test results for raw material, in-process, and final product samples.Evaluate and implement new test methods as appropriate.Interpret and apply evolving regulatory and quality standards.Interact with supply partners as required.Responsible for Batch review and approval, C of A creation, and CAPA process.Provide technical and quality operations support to other departmentsDrive efficiency, practices, and policies that improve quality.Analyze trends to improve quality and allocate resources for continuous improvement.Provide direction to Quality Engineers.Review processing documentation/records and create Certificates of GI and HI.Represent the company during customer audits and coordinate timely responses to audit findings.Investigate and ensure appropriate root cause analysis and effective CAPA implementation.Manage the Document Control system.Provide leadership and mentorship to the quality team.Perform other duties as assigned.

Knowledge skills and abilities:

Strong written and verbal communication skillsStrong analytical skillsDemonstrate strong presentation skillsAbility to lead cross functional teams to execute on complex tasks in a growing and changing environmentKnowledge and skills in root cause analysis and the CAPA processDemonstrated working with integrity and intensity

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions):

The work environment characteristics and physical effort described here are representative of those associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities.

While performing the duties of this job, the associate is exposed to an industrial warehouse environment.The associate may work near moving mechanical machinery. The physical requirements of the job are for associates to talk, hear, bend/stoop, squat, crawl, climb height, reach above shoulder height, crouch, kneel, balance, and push/pull.Associates use both hands for repetitive actions such as grasping and manipulating as well as both feet for repetitive movement operating foots controls. Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and the ability to adjust focus.Each employee is responsible to perform their defined tasks to maintain the site’s certifications and follow all regulatory requirements. The employee is expected to shut down the operation and notify management if an unsafe condition is observed or an instance of regulatory non-compliance that requires immediate attention arises. Regulatory requirements include, but are not limited to cGMPs, EPA, OSHA, DEA, DOT, and any other applicable local, governmental and company guidelines.

#LI-Onsite

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.