Senior QA Consultant - API External Manufacturing

BioSpace; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Job summary

Lilly in Indianapolis is seeking an API EM Quality Assurance Consultant to provide QA oversight across contract manufacturers and ensure GMP compliance. The role involves coordinating with CMs, supporting regulatory inspections, and reviewing batch documentation.

Required are a science degree and at least 2 years of GMP API/pharma experience, with US work authorization. Travel up to 20% may be required.

Qualifications

• Bachelor's degree in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
• At least 2 years GMP manufacturing experience in API or Pharma (finished product manufacturing, QC, QA or Engineering).
• Authorized to work in the United States on a full-time basis; Lilly will not sponsor work visas.

Responsibilities

• Serve as liaison between Contract Manufacturers (CMs) and Lilly for QA oversight.
• Provide quality oversight of CMs and act as initial contact for quality-related issues.
• Escalate quality issues at CMs to Lilly QA management.
• Assist in establishing and revising Quality Agreements with affiliates and customers.
• Ensure compliance with Quality Agreements and MRDs.

Skills

Quality assurance

GMP

Regulatory knowledge

Communication

Detail oriented

Cross-functional collaboration

Root cause analysis

Statistical skills

Documentation

Interpersonal skills

Education

Bachelor's degree in science related field

Job description

Lilly in Indianapolis is seeking an API EM Quality Assurance Consultant to provide QA oversight across contract manufacturers and ensure GMP compliance. The role involves coordinating with CMs, supporting regulatory inspections, and reviewing batch documentation.

Required are a science degree and at least 2 years of GMP API/pharma experience, with US work authorization. Travel up to 20% may be required.