Senior Representative

Description:

The Senior Representative, QA will be responsible for supporting supplier qualifications in the quality systems group. This role supports the organization's Quality Management System and oversight of supplier qualification compliance to Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This is a full-time, salaried position and is 100% site based. The schedule is Monday – Friday 1st shift.

Catalent Biologics in Bloomington, Indiana is a state-of-the-art, GMP manufacturing facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.
 

The Role

 

• Establish and maintain records of acceptable suppliers.
• Perform audit of various material and service suppliers.
• Assess incoming supplier change notifications and their impact to the organization.
• Negotiate and execute supplier quality contracts.
• Requalification activities of existing suppliers.
• Internal collaboration to determine new material supply chain qualification requirements.
• Other duties as assigned.
  
   

The Candidate

 

• Bachelor’s Degree in a STEM discipline, highly preferred.
• Minimum of 5 years relevant experience with a bachelor’s degree, required.
• Minimum of 8 years relevant experience or demonstrated excellence in role, with justification.
• Minimum of 2 years GxP experience, or other regulated industry.
• Prior experience in cGMP supplier quality management, highly preferred.
• Strong regulatory knowledge of industry standards related to GMP manufacturing, highly preferred.
• ASQ, Quality Auditor certification preferred.
• Must be able to read and understand English-written job instructions and safety requirements.