Senior Quality Engineer

Avantor, a Global Fortune 500 company, is looking for a dedicated Quality Assurance Professional to optimize our Performance Materials organization. This Phillipsburg, NJ role is full-time on-site, standard work hours

Minimum Education Requirement:

• Bachelor's Degree (chemistry or a related science).

Travel:

* Minimal domestic travel

Required Experience (5+ yrs):

• In quality assurance.
• Working within a regulated manufacturing environment.
• Working within cGMP/ISO 9000 regulated environment.
• Business level writing and presentation skills.
• Analytical/ problem solving skills.
• Navigating in a matrixed environment.
• Working collaboratively in a team environment.
• Collaborating effectively with people at multiple levels of an organization.
• Leading efforts in site quality assurance programs and improvement activities.
• Being responsible for identifying and implementing programs to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations as well as FDA requirements.
• Being accountable for direct support of several systems, including CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, and Validation.
• Leading programs and improvement activities focused on ensuring ongoing effectiveness of the quality management system in accordance with the ISO and GMP requirements.
• Leading customer complaint investigations requiring direct interaction with customers as well as raw material suppliers.
• Maintaining corrective and preventive action program activities within specific scope of responsibility to identify and implement effective corrective actions.
• Ensuring facility cGMP compliance is maintained.
• Identifying/implementing improvement programs.
• Providing GMP and GDP training to teams.
• Leading initiatives to drive improvement efforts in global metrics with specific focus on complaints, complaint response time and CAPAs.
• Performs other duties as assigned.

Preferred Experience:

• With chemical nomenclature and quality control testing / methods.
• Working with and providing input to the Management of Change (MOC) process.
• Working collaboratively with supplier quality personnel to identify and resolve quality issues impacting site performance and customer issues.
• Working with departments to investigate and resolve process/ product quality issues.
• Organization and project management experience.
• Performing internal and supplier audits.
• Performing statistical evaluations for processes.
• Leading validation activity associated with new products or changes to existing processes and products

How you will thrive and create an impact:

Serving customers worldwide, The Avantor Performance Materials organization manufactures and markets chemical products such as acids, advanced silicones, biological buffers, denaturants, and electronic chemicals, as well as diagnostics solutions.

The detail-oriented Quality Assurance Professional acts as the key contact/ SME working directly with customers to investigate and resolve complaints and inquiries to ensure expectations are met. This role will host and manage customer certification/surveillance audits and the internal audit program.

Working cross functionally in both a leadership and participative manner to integrate the necessary systems, the Quality Assurance Professional partners with external customers, operations leadership, and interacts with all levels of plant operations, R&D, procurement, commercial and quality teams. This vital team member will manage and lead audit activities within the site; including GMP, regulatory, customer and internal audits while recommending and implementing activities to close gaps identified in audits to ensure compliance with applicable requirements

WORKING CONDITIONS:

The work environment is a manufacturing facility, and the appropriate PPE will be required in designated areas..

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!

Pay Transparency:

The expected pre-tax pay for this position is

Actual pay may differ depending on relevant factors such as prior experience and geographic location.

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.comand 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 Know Your Rights poster.

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.

Avantor offers a comprehensive benefits package including medical, dental, and vision coverage, wellness programs, health savings and flexible spending accounts, a 401(k) plan with company match, and an employee stock purchase program. Employees also receive 11 paid holidays, accrue 18 PTO days annually, are eligible for volunteer time off and 6 weeks of 100% paid parental leave (except in states that offer paid family leave). These benefits may not apply to employees covered by a collective bargaining agreement or those subject to other eligibility rules.