Manufacturing QA Manager — FDA/QSR Expert, Onsite

Avantor; Phillipsburg (NJ); On-site; USD 94,000 - 157,000; Full time

Job summary

Avantor in Phillipsburg, NJ is seeking a Quality Assurance Manager (Manufacturing) to oversee QA activities across manufacturing units in line with QMS, FDA/ISO requirements, and certifications.

The role involves guiding QA associates, driving CAPA, internal audits, process documentation changes, and collaboration with customers and suppliers to ensure product quality and regulatory compliance.

Qualifications

• Bachelor's degree in life sciences or equivalent experience
• 5+ years in Quality Systems with supervisory experience preferred
• Strong knowledge of FDA and international Quality System regulations
• Strong communication and organizational abilities
• Proficiency with MS Word, Excel, PowerPoint and Access

Responsibilities

• Oversee Quality Assurance activities for manufacturing and site operations
• Guide QA associates and drive continuous improvement and CAPA
• Lead internal audits and QMS documentation updates
• Collaborate with customers and suppliers to address quality issues
• Ensure compliance with FDA, ISO, and other regulatory requirements
• Maintain training programs for QA staff and ensure proper reporting

Skills

Strong oral and written communication

FDA QA knowledge

Quality Systems

MS Word

MS Excel

PowerPoint

MS Access

Quality Management System

Education

Bachelor's Degree in a life science discipline

Job description

Avantor in Phillipsburg, NJ is seeking a Quality Assurance Manager (Manufacturing) to oversee QA activities across manufacturing units in line with QMS, FDA/ISO requirements, and certifications.

The role involves guiding QA associates, driving CAPA, internal audits, process documentation changes, and collaboration with customers and suppliers to ensure product quality and regulatory compliance.