Onsite QA Specialist - GMP Compliance & CI (Fremont)

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

Job summary

Boehringer Ingelheim Fremont is seeking a Specialist, Quality Assurance onsite in Fremont, CA. The role executes assigned quality activities to ensure compliance with product requirements, cGMP regulations, and internal quality policies.

You will lead cross-functional improvement efforts, support audits, and maintain readiness for inspections while collaborating with QA, QC, Operations, and MSAT to ensure high-quality product delivery.

Qualifications

• Bachelor's degree in a scientific discipline with 3+ years QA experience.
• Alternative: High School Diploma with 7+ years QA experience in life sciences.
• Must be legally authorized to work in the United States.

Responsibilities

• Execute quality activities to ensure compliance with product requirements and cGMP regulations.
• Maintain product integrity and align with quality systems.
• Lead minor cross-functional continuous improvement initiatives.
• Collaborate with peers and partner functions to improve processes and resolve issues.
• Support CAPA activities and SOP/documentation updates.
• Assist in data collection, trending, and KPI reporting.

Education

Bachelor's degree in a scientific discipline

High School Diploma + 7 years experience in Quality-related roles

Job description

Boehringer Ingelheim Fremont is seeking a Specialist, Quality Assurance onsite in Fremont, CA. The role executes assigned quality activities to ensure compliance with product requirements, cGMP regulations, and internal quality policies.

You will lead cross-functional improvement efforts, support audits, and maintain readiness for inspections while collaborating with QA, QC, Operations, and MSAT to ensure high-quality product delivery.