Onsite Quality Assurance Specialist – GMP & Audits

Boehringer Ingelheim GmbH; Fremont (CA); On-site; USD 75,000 - 112,000; Full time

Benefits offered by this job

Discretionary bonus

Job summary

Boehringer Ingelheim Fremont is seeking a Specialist, Quality Assurance onsite in Fremont, CA. You will execute quality activities to ensure compliance with product requirements, cGMP, and internal policies, while maintaining product integrity and readiness for audits.

This role emphasizes cross-functional collaboration, data trending, CAPA support, and timely documentation to enable high-quality product delivery.

Qualifications

• Requires a bachelor’s degree in a scientific field with 3+ years quality experience.
• Alternate: HS diploma with 7+ years life sciences QA experience.
• Experience with cGMP and regulatory standards preferred.

Responsibilities

• Execute quality activities to ensure compliance with product requirements.
• Maintain product integrity and alignment with quality systems.
• Lead minor cross-functional improvement initiatives.
• Support CAPA, trending, and documentation for readiness.
• Represent site during audits and inspections.

Skills

Quality Assurance

cGMP

Documentation

Audit readiness

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

High School Diploma + 7 years QA experience

Tools

CAPA systems

Quality Management System

SOP compliance

Job description

Boehringer Ingelheim Fremont is seeking a Specialist, Quality Assurance onsite in Fremont, CA. You will execute quality activities to ensure compliance with product requirements, cGMP, and internal policies, while maintaining product integrity and readiness for audits.

This role emphasizes cross-functional collaboration, data trending, CAPA support, and timely documentation to enable high-quality product delivery.