Senior QA Auditor & Supplier Quality Lead

Seranbio; Bend (OR); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Life Insurance

Employee Assistance Program

Pet Insurance

Job summary

Serán BioScience in Bend, Oregon, is seeking a Quality Assurance Senior Specialist to lead day-to-day QA activities for a GMP facility that manufactures, stores, and tests pharmaceutical products. You will oversee supplier quality, audits, and the Quality Risk Management program.

Responsibilities include audit management and responses, CAPA planning, SOP/document control, and collaboration across cross-functional teams.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 8+ years of QA experience with auditing and supplier quality.
• Experience with GMP, FDA/regulatory expectations.

Responsibilities

• Performs internal and third-party audits.
• Supports regulatory inspections and client audits.
• Oversees supplier quality program and audit activities.

Skills

Auditing

Supplier Quality

Regulatory inspections

GMP knowledge

Veeva experience

Education

Bachelor's Degree in life sciences or related field

Tools

Veeva

Job description

Serán BioScience in Bend, Oregon, is seeking a Quality Assurance Senior Specialist to lead day-to-day QA activities for a GMP facility that manufactures, stores, and tests pharmaceutical products. You will oversee supplier quality, audits, and the Quality Risk Management program.

Responsibilities include audit management and responses, CAPA planning, SOP/document control, and collaboration across cross-functional teams.