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.
Quality Engineer II at Avantor summary:
As a Quality Engineer II at Avantor, I lead initiatives to enhance quality assurance programs and align with industry regulations in a chemical manufacturing setting. My role involves managing compliance with cGMPs and ISO standards, conducting internal and supplier audits, and driving improvements in quality metrics and complaint responses. With over five years of experience in quality engineering, I collaborate across departments to resolve quality issues and ensure effective corrective actions are implemented.
Keywords:
Quality Engineer, cGMP, ISO Compliance, Quality Assurance, Pharmaceutical Manufacturing, Complaint Investigation, Regulatory Compliance, Quality Control, CAPA, Chemical Manufacturing
