Quality Engineer II

The Opportunity:

Avantor is looking for a Quality Engineer II to support our chemical manufacturing facility in Phillipsburg, NJ The Quality Engineer II leads efforts in site quality assurance programs and improvement activities. He/she is responsible for identifying and implementing programs to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations as well as FDA requirements. 

The Quality Engineer II is accountable for direct support of several systems, including CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC (supporting the microelectronic, pharmaceutical and reagent product lines as necessary) and Validation.

This is a full-time, onsite position in Phillipsburg, NJ (1st Shift, Monday – Friday).

What we’re looking for  

• Education: Bachelor’s Degree in chemistry or a related field required

• Experience:  Minimum of five (5) years of experience in quality engineering or a related role required

• Experience working within pharmaceutical, biotechnology and/or chemical environments required

• Experience working within cGMP/ISO 9000 regulated environments required

• Excellent writing and presentation skills

• Demonstrated ability to accomplish goals through others

• Demonstrated familiarity with chemical nomenclature and Quality Control testing and methods

• Ability to merge divergent resources into an effective and efficient cross-functional team

• Highly detail oriented with demonstrated strong analytical and problem-solving skills

• Ability to navigate in a matrixed environment and work collaboratively in a team environment

• Excellent organization and project management skills

• Ability to interface effectively with people at all levels of the organization, from executive to production line

How you will thrive and create an impact  

• Leads programs and improvement activities focused on ensuring ongoing effectiveness of the quality management system in accordance with the ISO and GMP requirements

• Leads customer complaint investigations requiring direct interaction with customers as well as raw material suppliers

• Manages and leads audit activities within the site including GMP, regulatory, customer and internal audits; recommends and implements activities to close gaps identified in audits to ensure compliance with applicable requirements

• Performs internal audits at other Avantor sites and may participate in supplier audits as required

• Responsible for maintaining Corrective and Preventive Action program activities within specific scope of responsibility to identify and implement effective corrective actions

• Ensures facility cGMP compliance is maintained and identifies/implements improvement programs as required

• Provides GMP and GDP training to site personnel

• Leads efforts to drive improvement efforts in global metrics with specific focus on complaints and complaint response time as well as CAPAs

• Works with and provides input to Management of Change process

• Performs statistical evaluations for processes and trending and leads validation activity associated with new products or changes to existing processes and products

• Works collaboratively with supplier quality personnel to identify and resolve quality related issues impacting site performance as well as customer complaint

• Partners collaboratively with external customers, operations leadership, and interacts with all levels of plant operations, R&D, procurement, commercial and quality teams

• Works with all departments to investigate and resolve process and product quality issues

• Performs other duties as assigned with or without accommodation

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.

The Quality Engineer II at Avantor is responsible for leading quality assurance programs within a chemical manufacturing facility, ensuring compliance with regulatory standards such as cGMP, ISO, and FDA requirements. This role involves managing CAPA systems, investigating customer complaints, conducting audits, and collaborating with cross-functional teams to enhance the quality management system. The position requires a Bachelor's degree in chemistry or a related field, along with a minimum of five years' experience in quality engineering, particularly in the pharmaceutical or biotechnology sectors.

Quality Engineer, cGMP compliance, ISO standards, Quality Assurance, Pharmaceutical manufacturing, Complaint investigation, CAPA, Regulatory compliance, Statistical analysis, Team collaboration