Pharma Quality Agreements Lead | Compliance & Collaboration

vwr; Phillipsburg (NJ); On-site; USD 75,000 - 95,000; Full time

Job summary

Avantor is seeking a Quality Agreement Specialist to support QA operations, ensure regulatory compliance and drive quality improvements. The role collaborates with internal teams and suppliers to resolve quality issues and develops quality documentation and customer agreements.

Based in Phillipsburg or Bridgeport, NJ, it offers full-time employment with travel up to 10%. The ideal candidate has a BS/BA in a related science, 3+ years in chemical/pharma environments, and experience with cGMP, FDA,

Qualifications

• BS/BA degree in Biology, Biotechnology, Bio Engineering, Chemistry, Chemical Engineering, or related field required.
• Minimum of three years of experience in technical services, engineering, quality or sales in chemical or pharmaceutical environments.
• Experience in synthetic pharmaceutical & biopharmaceutical development and manufacturing and understanding of industry regulations (cGMP, FDA, ICH, WHO).
• Quality and process engineering experience in chemical or pharmaceutical environments.
• Proficiency with Microsoft Office; experience with databases and ability to develop technical skills.
• Hands-on laboratory or manufacturing experience is preferred.
• Project management experience is desirable.
• Experience in at least one of the following areas is highly desired.

Responsibilities

• Provide technical and quality support to Avantor's global customer and sales teams.
• Research, compile and communicate information related to Avantor's pharmaceutical and laboratory product offerings.
• Develop and maintain quality documentation; update product and customer databases; manage customer Quality Agreements.
• Manage and negotiate Customer Quality Agreements with Avantor legal team.
• Respond to customers' technical and quality inquiries via telephone and email related to product lines and quality agreement support.
• Review technical documents and product specifications; use monographs, R&D experts, internal databases to prepare quality agreements.
• Design/improve quality agreement information collection and archiving with Marketing, Sales, and Quality Assurance.
• Participate in lean process reviews to maximize team efficiency in customer responses.
• Participate on cross-functional teams for customer intimacy programs; may include project management and data handling.
• Perform other duties as assigned; travel may be required.

Skills

Quality assurance

Regulatory knowledge

Project management

Problem solving

Education

BS/BA degree

Tools

Microsoft Office Suite

Databases

Job description

Avantor is seeking a Quality Agreement Specialist to support QA operations, ensure regulatory compliance and drive quality improvements. The role collaborates with internal teams and suppliers to resolve quality issues and develops quality documentation and customer agreements.

Based in Phillipsburg or Bridgeport, NJ, it offers full-time employment with travel up to 10%. The ideal candidate has a BS/BA in a related science, 3+ years in chemical/pharma environments, and experience with cGMP, FDA,