Senior Quality Engineer

The Opportunity:

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 pa