Senior QA Lead - Early-Phase Biotech Ops

Arrowhead Pharmaceuticals, Inc.; Verona (WI); On-site; USD 78,000 - 98,000; Full time

Benefits offered by this job

Excellent benefits

On-site in Verona, WI

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking a QA Specialist III for Early Phase Quality Operations in Verona, WI. The role focuses on QA support for early phase clinical programs and collaboration with contract manufacturers, testing labs, and labeling vendors.

Responsibilities include reviewing vendor documentation, lot disposition, and coordinating with internal teams to ensure GMP compliance. The position requires strong attention to detail and effective communication with external partners,

Qualifications

• Bachelor's degree in a scientific field (chemistry, biology, biochemistry).
• Minimum 5 years of QA or related experience in biotech/pharma.
• Experience reviewing batch records, COAs, and testing records from external vendors.
• Strong written and verbal communication; detail-oriented and organized.

Responsibilities

• Provide QA support for early phase clinical programs.
• Act as QA contact for CDMOs/CMOs and other vendors.
• Review and approve vendor documentation against specs and IND/CTA/IMPD.
• Review labeling records and perform lot disposition; prepare CoC as needed.
• Assist with vendor quality metrics and document control tasks.

Skills

GMP knowledge

GCP knowledge

ICH guidance

Quality systems

Education

BS/BA in chemistry, biology, or biochemistry

Tools

EDMS

Adobe Acrobat

Microsoft Office

SmartSheet

Job description

Arrowhead Pharmaceuticals, Inc. is seeking a QA Specialist III for Early Phase Quality Operations in Verona, WI. The role focuses on QA support for early phase clinical programs and collaboration with contract manufacturers, testing labs, and labeling vendors.

Responsibilities include reviewing vendor documentation, lot disposition, and coordinating with internal teams to ensure GMP compliance. The position requires strong attention to detail and effective communication with external partners,